Fluid-Management System and Method

ABSTRACT

A fluid-management system for selectively draining fluid from a body cavity includes a valve assembly and a tube for carrying fluid from a body cavity of a person to the valve assembly. The valve assembly is configured to be positioned external to the person&#39;s body and comprises (i) an inlet, (ii) an outlet, (iii) a pumping chamber between the inlet and outlet and configured to be compressed and decompressed to pump fluid, (iv) a first one-way valve positioned on a first side of the pumping chamber, (v) a second one-way valve positioned on a second side of the pumping chamber, and (vi) an adjustable inlet lock configured to selectively prevent fluid movement through the inlet, and wherein the tube is configured to extend from the inlet of the valve assembly to the person&#39;s body cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of, and claims the benefit ofpriority under 35 U.S.C. § 120 to, U.S. Non-Provisional patentapplication Ser. No. 17/733,138, filed on Apr. 29, 2022 and entitled“Fluid-Management System and Method,” the contents of which areincorporated herein by reference in its entirety.

BACKGROUND

A number of techniques for draining bodily fluid involve utilizing apump, in combination with a tube (e.g., a shunt or catheter), to drainfluid from one cavity within the human body to either another cavitywithin the body or to a reservoir outside of the body. Such techniquesmay be utilized for purposes including, for example, draining a person'sblood, urine, saliva, cerebrospinal fluid, peritoneal fluid, pleuralfluid, and/or cystic-lesion fluid, among other possibilities.

Overview

When fluid builds up in a cavity of a person's body, it is oftennecessary to drain the fluid to either another cavity within the body orto outside of the body. Fluid may build up for one reason or another invarious body cavities such as a pleural cavity, a peritoneal cavity, acerebrospinal cavity, a breast cavity, a cavity of a cystic lesion inthe body (e.g., a cystic lesion in the breast, a cystic lesion in theabdomen, etc.), a cavity left following surgery, among otherpossibilities.

In some situations, it may be desirable to drain fluid by moving thefluid (i) from a body cavity, (ii) through an implanted tube in fluidcommunication with the body cavity, and (iii) into an external reservoirlocated outside the person's body. Further, in some situations, it mayalso be desirable for a person to not have a permanently-attachedexternal drainage reservoir attached to the implanted tube that is influid communication with the body cavity, but rather have the ability tointermittently drain the body cavity into an external drainage reservoirwhen convenient for the person. Such selective draining of fluid fromthe body cavity may, for instance, help a person drain fluid build-upbefore the fluid build-up becomes uncomfortable while also avoiding theneed for a permanently-attached external drainage reservoir. Allowing aperson to control when to selectively drain fluid and avoiding the needfor a permanently-attached external drainage reservoir may provide aperson greater freedom and flexibility compared to a situation in whicha person is unable to selectively control when to drain fluid and/or hasa permanently-attached external drainage reservoir.

One example situation in which it may be desirable to selectively drainfluid from a person's body cavity into an external drainage reservoirthat is not permanently attached to the person is drainage of pleuralfluid for the treatment of pleural effusions. Pleural fluid is normallya low-protein liquid that can be found in relatively small amounts(normally 10-20 milliliters) in each of a person's pleural cavities. Thepleural cavities are the spaces between the visceral pleura (i.e., themembrane located over the entire outer surface of each lung) and theparietal pleura (i.e., the membrane lining the inside of the chest wallof each hemithorax). The small amount of pleural fluid in each pleuralspace is spread out very thinly between the visceral and parietal pleurathereby providing for a large surface tension which mechanically couplesthe lung to the chest wall while simultaneously lubricating thesesurfaces allowing the lung to slide over the chest wall during thebreathing process. In a normal, healthy person, pleural fluid isconstantly being produced—largely from leakage of fluid from blood andlymphatic vessels in the visceral pleura that coats the outer surface ofthe lung—and reabsorbed at essentially the same rate by lymphaticchannels located in the parietal pleural that lines the chest wall. Thisdynamic balance exchanges the fluid multiple times a day and typicallymaintains a low total volume in the 10-20 milliliter range. However,under certain abnormal conditions, such as infection, inflammation,malignancy, heart failure, liver failure, or kidney failure, among otherpossible conditions, the net flow of pleural fluid within the pleuralcavity becomes unbalanced, with increased fluid production and/ordecreased reabsorption, resulting in the excess accumulation (e.g., onthe order several hundred milliliters to several liters) of fluid in thepleural space.

Excess accumulation of pleural fluid is known as pleural effusion andadds additional mass that must be moved with each breath and may causethe pathological compression of lung tissue. This compression results inconsiderable difficulty in or prevention of the breathing process.Pleural effusion may lead to various issues, such as dyspnea, shortnessof breath, chest pain, and/or chronic cough, among other possibilities,and may greatly compromise a person's quality of life. Draining of theexcess accumulation of pleural fluid may help to alleviate, reduce oreliminate such issues. Treatment of a pleural effusion may involvedraining of pleural fluid into either another body cavity or outside ofthe body, and in some situations, it may be desirable to treat a pleuraleffusion by selectively draining fluid from the pleural cavity into anexternal reservoir.

While there are certain fluid-management systems existing that allow aperson to selectively control when to drain excess fluid from a bodycavity (e.g., a pleural cavity) via an implanted tube such that anexternal reservoir is not always attached to the implanted tube, theseexisting fluid-management systems typically utilize a dedicatedpump-and-reservoir assembly that can be removably attached to theimplanted tube. The dedicated pump-and-reservoir assembly includes anactive pumping component for pumping fluid out of the body cavity and adrainage reservoir for collecting the pumped fluid. The active pumpingcomponent serves to force fluid to move through the implanted tube andinto the drainage reservoir. In an example, the active pumping componentis a vacuum-based component that is configured to provide vacuumpressure to facilitate draining from the body cavity. For instance, inan example, a dedicated pump-and-reservoir assembly includes a vacuumbottle that, upon attachment to the implanted tube and activation of thevacuum (e.g., via breaking of a vacuum seal of the vacuum bottle),provides vacuum pressure to move fluid from the person's body cavity,through the implanted tube, and into the vacuum bottle.

When a person desires to drain the fluid within the body cavity using adedicated pump-and-reservoir assembly, the person needs to (i) accessthe dedicated pump-and-reservoir assembly, (ii) sterilize both thecomponent(s) of the dedicated pump-and-reservoir assembly to beconnected to the implanted tube and the attachment point of theimplanted tube, (iii) attach the dedicated pump-and-reservoir assemblyto the implanted tube, and (iv) activate the active pumping component tofacilitate draining of the body cavity. Further, after completingdraining of the body cavity, the person then needs to detach thededicated pump-and-reservoir assembly from the implanted tube, as wellas decontaminate and sterilize the attachment point of the implantedtube. However, the existing fluid-management systems such as this thatallow a person to selectively control when to drain excess fluid from abody cavity by utilizing a dedicated pump-and-reservoir assembly havenumerous drawbacks.

One such drawback of existing fluid-management systems is that a personcannot drain fluid from the body cavity with the implanted tube unlessthe person has access to the dedicated pump-and-reservoir assembly.However, in practice, it is often difficult and/or inconvenient for aperson to always bring with them a dedicated pump-and-reservoir assemblyor otherwise ensure that they always have access to the dedicatedpump-and-reservoir assembly when needed. For instance, the dedicatedpump-and-reservoir assemblies can be bulky and/or difficult transport.Further, people may often forget to bring a dedicated pump-and-reservoirassembly with them (e.g., when leaving the person's house for one reasonor another, the person may forget the dedicated pump-and-reservoirassembly and instead leave it at home). Therefore, with the existingfluid-management systems, a person may be unable to drain fluid from thebody at the desired or needed time.

Another drawback of existing fluid-management systems is that thededicated pump-and-reservoir assemblies may be costly and/or difficultfor a person to obtain. For instance, the dedicated pump-and-reservoirassemblies may be single-use assemblies that are disposed of afterdraining, and these may be costly for persons using the assembliesand/or insurance companies for persons using the assemblies. Further, insome examples, the dedicated pump-and-reservoir assembly includes areusable pumping component (e.g., a reusable motorized peristaltic pump)and a single-use dedicated drainage line and reservoir, and these may becostly for persons using the assemblies and/or insurance companies forpersons using the assemblies. Such cost issues may make it difficult fora person to obtain the dedicated pump-and-reservoir assemblies. Further,it may be difficult for a person to always have a dedicatedpump-and-reservoir assembly on hand and/or obtain a dedicatedpump-and-reservoir assembly when needed. Such issues may in turn reducecompliance with a person's treatment plan (e.g., a doctor-specifieddraining schedule for draining the body cavity).

Yet another example drawback of existing fluid-management systems isthat the process of connecting the dedicated pump-and-reservoir assemblyto the implanted tube can be a cumbersome process.

Still yet another example drawback of existing fluid-management systemsis that the task of connecting the components(s) of the dedicatedpump-and-reservoir assembly to the attachment point of the implantedtube may be associated with a risk of contamination (e.g., if one ormore of the components being attached is not sterile). Further,contamination may be associated with a risk of infection, and existingfluid-management systems have a reported infection rate of approximately5-10%. In existing fluid-management systems, the reservoir andattachment line are typically single-use and provided sterile. Theimplanted tube to which the reservoir and attachment line are attachedis typically decontaminated, for example, with an alcohol swab orbetadine swab. The sterile, disposable, attachment line is thenconnected to this decontaminated portion of the implanted tube. In someexisting fluid-management systems, the sterile part is passed throughthe decontaminate part and into the interior of the implanted tube thatis in direct fluid communication with the pleural space. Infection mayoccur during use of existing fluid-management systems for variousreasons, such as bacterial colonization of the implanted tube entrypoint and/or the distal access of the implanted tube itself. Further, inexisting fluid management systems, when the implanted tube is accessed,the systems do not actively prevent retrograde flow (also referred toherein as “backflow”) during the draining process, and backflow may beassociated with a risk on contamination and/or infection.

To help address the aforementioned and other problems, disclosed hereinis new fluid-management system for selectively draining fluid from abody cavity. The disclosed fluid-management system includes a valveassembly and a tube for carrying fluid from a body cavity of a person tothe valve assembly. The valve assembly is configured to be positionedexternal to the person's body and comprises (i) an inlet, (ii) anoutlet, (iii) one or more one-way valves positioned between the inletand outlet that are each configured to open and close based onfluctuations in pressure between the person's body cavity and theone-way valve, and (iv) an adjustable outlet lock configured toselectively prevent fluid movement through the outlet. In someimplementations, the one or more one-way valves of the valve assemblymay take the form of a single one-way valve, while in otherimplementations, the one or more one-way valves of the valve assemblymay take the form of two one-way valves arranged in series, among otherpossibilities. In implementations where the one or more one-way valvesof the valve assembly take the form of two one-way valves arranged inseries, the two one-way valves of the valve assembly may be arranged inseries within a pumping chamber that is configured to allow a person toprime the fluid-management system. The tube may be configured to extendfrom the inlet of the valve assembly to the person's body cavity andallow movement of fluid from the person's body cavity to the inlet ofthe valve assembly. In this way, the fluid-management system may beselectively used by the person to drain fluid into any appropriateexternal reservoir, such as a sink, a commode, and/or a containerprovided by the person, among other possibilities.

As noted, the one or more one-way valves are each configured to open andclose based on fluctuations in pressure between the body cavity and theone-way valve, which allows fluid movement out of the outlet and alsoprevents retrograde flow (also referred to herein as “backflow”) in thefluid-management system (e.g., flow of liquid and/or air back into thetube). In practice, retrograde flow may result in aspiration of air backinto the body cavity (e.g., a pleural cavity) or flow of liquid backinto the cavity, and such retrograde flow could cause various issuessuch as infection by allowing bacterial entry and/or collapse of thelung. Therefore, preventing retrograde may help to avoid such issuesthat may be associated with flow of liquid and/or air back into thetube.

Additionally, the opening and closing of the one or more one-way valvesmay also provide a pumping action that helps move fluid from the cavitythrough the tube and the valve assembly. In this regard, in someexamples, the fluctuations in pressure between the body cavity and theone or more one-way valves occur based on respiratory action of abreathing cycle of the person. As one possibility, when the body cavityis the pleural cavity, pressure between the body cavity and the one ormore one-way valves swings from positive to negative during thebreathing cycle. Based on these fluctuations in pressure between thebody cavity and the one or more one-way valves, the one or more one-wayvalves will close during inspiration (when pressure is negative) andopen during expiration (when pressure is positive). As such, in anexample, the valve assembly can provide a pump action with energyprovided by the respiratory action of the person draining fluid from thebody cavity. Given this opening and closing due to respiratory action,the valve assembly can act as a pump to move fluid from the body cavity,through the tube, through the one or more one-way valves, and out theoutlet.

In at least some implementations, the one or more one-way valves mayeach be configured to have a low “cracking pressure,” such that theone-way valve is configured to transition from a closed state to an openstate with relatively small differential pressures across the one-wayvalve. For instance, the cracking pressure of each one-way valve canrange anywhere from about 25 cmH₂O or less to about 5 cmH₂O or less, andas specific examples, the cracking pressure of a given one-way valvecould be less than about 25 cmH₂O, less than about 15 cmH₂O, less thanabout 10 cmH₂O, or less than about 5 cmH₂O. Further, in at least someimplementations, the one or more one-way valves may also each beconfigured to have a low “resealing pressure,” such that the one-wayvalve is configured to transition from an open state to a closed statewith small differential pressures across the one-way valve. Forinstance, the resealing pressure of each one-way valve can rangeanywhere from about 15 cmH₂O or less to about 2 cmH₂O or less, and asspecific examples, the cracking pressure of a given one-way valve couldbe less than about 15 cmH₂O, less than about 10 cmH₂O, less than about 5cmH₂O, or less than about 2 cmH₂O.

Further yet, the cracking pressure and/or the resealing pressure foreach of the one or more one-way valves may be selected based on any ofvarious factors, an example of which may be the type of cavity fromwhich the fluid-management system is intended to drain fluid, amongother examples.

In operation, prior to draining the body cavity using the disclosedfluid-management system, a person may first select an external reservoirin which to drain the fluid from the body, such as a sink, a commode,and/or a container provided by the person, among other possibilities.Next, to initiate the draining process, the person may switch theadjustable outlet lock of the valve assembly to an unlocked position.When the adjustable outlet lock is in the unlocked position, fluid maybegin moving through the fluid-management system due to the pressure ofthe body cavity and/or the pumping action provided by the valveassembly. This will move fluid from the cavity, through the tubeextending from the cavity to the inlet of the system, through the one ormore one-way valves of the system, and then out of the outlet of thesystem and into the external reservoir. After the draining process hasbegun, the person may drain the fluid from the cavity until the cavityis empty and/or a desired amount of fluid has been drained from thecavity. Finally, after draining is complete, the person maydecontaminate the outlet and/or adjustable lock of the valve assemblyand switch the adjustable lock into the locked position. Alternatively,the adjustable lock could be a locking cap that can be attached to thecatheter assembly to seal the valve assembly and prevent fluid flow orremoved to allow fluid flow. At the conclusion the cap can bedecontaminated and reattached or a new cap can be attached.

The disclosed fluid-management system may also be designed such that,when a sufficient amount of fluid has moved through the fluid-managementsystem, a siphon effect can be utilized to help to more quickly drainthe fluid from the cavity. For instance, the disclosed fluid-managementsystem may be designed such that the pressure of the body cavity and/orpumping action provided by the valve assembly may allow a column offluid to form within the tube that in turn leads to a siphon effect. Theheight of this column of fluid can be increased by the patient sittingup or standing or by lowering the distal end of the tube. In otherwords, the disclosed fluid-management system may be designed such that,once the tube is primed by the valve assembly, fluid from the cavity canbe siphoned out.

As mentioned above, in some implementations, the one or more one-wayvalves of the valve assembly may take the form of a single one-wayvalve, whereas in other implementations, the one or more one-way valvesof the valve assembly may take the form of two one-way valves arrangedin series. As also mentioned above, in either of these arrangements, theone or more one-way valves are each configured to open and close basedon fluctuations in pressure between a cavity of a person's body and theone-way valve, or fluctuations in pressure between a cavity of aperson's body and the first one-way valve and fluctuations in pressurebetween the first one-way valve and the second one-way valve.Furthermore, in implementations where the one or more one-way valves ofthe valve assembly take the form of two one-way valves arranged inseries, the two one-way valves may allow for additional capabilitiesand/or benefits relative to a valve assembly having a single one-wayvalve, including but not limited to improving the flow of fluid movementin the fluid-management system (e.g., when used together with a pumpingchamber) and/or providing an additional barrier to retrograde flow,among other possibilities.

For instance, in at least some implementations, the two one-way valvesof the valve assembly may be arranged in series within a pumpingchamber, where a first one-way valve may be positioned on a first sideof the pumping chamber proximate to the inlet of the valve assembly anda second one-way valve may be positioned on a second side of the pumpingchamber proximate to the outlet of the valve assembly. Such a pumpingchamber may be formed from a resiliently flexible material that may becompressed and decompressed to provide a pumping action to prime thefluid-management system and get fluid moving through thefluid-management system. In this respect, cyclical compression anddecompression of the resiliently flexible material may draw fluid (e.g.,liquid and/or air) from the inlet, through the first one-way valve intoan interior space of the pumping chamber, through the second one-wayvalve, and out the outlet of the valve assembly. Such a two-valveconfiguration may thus allow a person to prime the fluid-managementsystem, which may help to speed up the draining process by getting fluidto move more quickly through the fluid-management system. Such atwo-valve configuration may also allow for the generation ofsupraphysiologic positive and/or negative pressures, which may also beof benefit to clear debris from within the tubing, from within theone-way valves, and/or from within other regions of the valve assembly.

Further, in at least some implementations, the fluid-management systemincludes a valve assembly and a tube for carrying fluid from a bodycavity of a person to the valve assembly, wherein the valve assembly isconfigured to be positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) a pumping chamber between the inletand outlet and configured to be compressed and decompressed to pumpfluid, (iv) a first one-way valve positioned on a first side of thepumping chamber, (v) a second one-way valve positioned on a second sideof the pumping chamber, and (vi) an adjustable inlet lock configured toselectively prevent fluid movement through the inlet, and wherein thetube is configured to extend from the inlet of the valve assembly to theperson's body cavity.

Still further, in at least some implementations, the fluid-managementsystem includes a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly, wherein the valveassembly is configured to be positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) a pumping chamberbetween the inlet and outlet and configured to be compressed anddecompressed to pump fluid, (iv) a first one-way valve positioned on afirst side of the pumping chamber, (v) a second one-way valve positionedon a second side of the pumping chamber, (vi) an adjustable inlet lockconfigured to selectively prevent fluid movement through the inlet, andwherein the tube is configured to extend from the inlet of the valveassembly to the person's body cavity, and (vii) an adjustable outletlock configured to selectively prevent fluid movement through theoutlet, wherein the adjustable inlet lock is positioned upstream of thefirst one-way valve, and wherein the adjustable outlet lock ispositioned downstream of the second one-way valve.

The fluid-management system (and method of operation) disclosed hereinmay provide various benefits over existing fluid-management systems thatallow a person to selectively control when to drain excess fluid from abody cavity to an external reservoir, such as a fluid-management systemthat is based on a dedicated pump-and-reservoir assembly.

For instance, the valve assembly of the disclosed fluid-managementsystem is configured to leverage pressure gradients produced withrespect to the body cavity and the valve system to drain fluid from thebody cavity rather than relying on an active, vacuum-based pumpingcomponent (which involves larger, heavier, and more expensivecomponents). Further, the valve assembly of the disclosedfluid-management system is not integrated into a dedicatedpump-and-reservoir assembly and can be used to drain fluid from the bodycavity into any available reservoir at any time. As a result, thedisclosed fluid-management system is smaller, lighter, and more portablethan existing fluid-management systems. The fluid-management system canthus remain with the person at all times (e.g., the external portion ofthe fluid-management system can be coiled and taped to a person's bodyor tucked into clothing when not in use) and does not require that theperson have access to a dedicated pumping-and-reservoir assembly.

Further, given that the fluid-management system does not rely of anactive, vacuum-based component and is not integrated into a dedicatedpump-and-reservoir assembly, the disclosed fluid-management system isless costly (e.g., for persons using the assemblies and/or insurancecompanies for persons using the assemblies) than existingfluid-management systems.

Still further, by avoiding the need to attach a dedicatedpump-and-reservoir assembly to the implanted tube and also detach thededicated pump-and-reservoir assembly from the implanted tube each timea person drains the body cavity, the draining process using thedisclosed fluid-management system is less cumbersome compared todraining processes using the existing fluid-management systems.

Yet still further, as noted above, the existing draining processesinvolve connecting components(s) of the dedicated pump-and-reservoirassembly to the attachment point of the implanted tube, which may beassociated with a risk of contamination (e.g., if one or more of thecomponents being attached is not sterile). By avoiding the need toattach a dedicated pump-and-reservoir assembly to the implanted tube andalso detach the dedicated pump-and-reservoir assembly from the implantedtube each time a person drains the body cavity, the disclosedfluid-management system also reduces a risk of contamination compared tothe existing fluid-management systems. And yet still further, as notedabove, in existing fluid management systems, when the implanted tube isaccessed, the systems do not actively prevent backflow during thedraining process. The disclosed fluid-management system includes one ormore one-way valves configured to prevent backflow in thefluid-management system both during the draining process as well as whenthe adjustable outlet lock is closed. Actively preventing backflowreduces a risk of contamination and/or infection compared to theexisting fluid-management systems.

Accordingly, in one aspect, disclosed herein is a fluid-managementsystem comprising a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly. The valve assembly isconfigured to be positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) one or more one-way valvespositioned between the inlet and outlet that are each configured to openand close based on fluctuations in pressure between the person's bodycavity and the one-way valve, and (iv) an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet.

In another aspect, disclosed herein is a fluid-management systemcomprising a valve assembly and a tube for carrying fluid from a bodycavity of a person to the valve assembly. The valve assembly isconfigured to be positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) a plurality of one-way valvespositioned between the inlet and outlet that are each configured to openand close based on fluctuations in pressure between the person's bodycavity and the one-way valve, and (iv) an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet. Inat least some implementations, the plurality of one-way valves may bearranged in series. Further, the tube is configured to extend from theinlet of the valve assembly to the person's body cavity.

In yet another aspect, disclosed herein is a method of operation of afluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly. Thevalve assembly is positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) one or more one-way valvespositioned between the inlet and outlet that are each configured to openand close based on fluctuations in pressure between the person's bodycavity and the one-way valve, and (iv) an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet. Themethod includes while the adjustable outlet lock is in a lockedposition, the adjustable outlet lock preventing fluid movement throughthe outlet. The method further includes while the adjustable outlet lockis in an unlocked position, each of the one or more one-way valvesopening and closing based on fluctuations in pressure between theperson's body cavity and the one-way valve, so as to provide a pumpingaction to move fluid from the body cavity through the tube, into theinlet, and out of the outlet to an exterior reservoir. In at least someimplementations, the fluctuations occur based on respiratory action of abreathing cycle of the person.

In still yet another aspect, disclosed herein is a method for fluidmanagement that includes providing a fluid-management system comprisinga valve assembly and a tube for carrying fluid from a body cavity of aperson to the valve assembly, where the valve assembly is configured tobe positioned external to the person's body and comprises (i) an inlet,(ii) an outlet, (iii) one or more one-way valves positioned between theinlet and outlet that are each configured to open and close based onfluctuations in pressure between a cavity of a person's body and theone-way valve, and (iv) an adjustable outlet lock configured toselectively prevent fluid movement through the outlet. The methodfurther includes implanting a portion of the fluid-management systeminto the person's body, such that a proximal end of the tube is in fluidcommunication with the cavity and the valve assembly is positionedexternal to the person's body.

In still yet another aspect, disclosed herein is a fluid-managementsystem comprising a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly. The valve assembly isconfigured to be positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) a pumping chamber between the inletand outlet and configured to be compressed and decompressed to pumpfluid, (iv) a first one-way valve positioned on a first side of thepumping chamber, (v) a second one-way valve positioned on a second sideof the pumping chamber, and (vi) an adjustable inlet lock configured toselectively prevent fluid movement through the inlet, and wherein thetube is configured to extend from the inlet of the valve assembly to theperson's body cavity.

In still yet another aspect, disclosed herein is a fluid-managementsystem comprising a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly. The valve assembly isconfigured to be positioned external to the person's body and comprises(i) an inlet, (ii) an outlet, (iii) a pumping chamber between the inletand outlet and configured to be compressed and decompressed to pumpfluid, (iv) a first one-way valve positioned on a first side of thepumping chamber, (v) a second one-way valve positioned on a second sideof the pumping chamber, (vi) an adjustable inlet lock configured toselectively prevent fluid movement through the inlet, and wherein thetube is configured to extend from the inlet of the valve assembly to theperson's body cavity, and (vii) an adjustable outlet lock configured toselectively prevent fluid movement through the outlet, wherein theadjustable inlet lock is positioned upstream of the first one-way valve,and wherein the adjustable outlet lock is positioned downstream of thesecond one-way valve.

In still yet another aspect, disclosed herein is a method of operationof a fluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly,wherein the valve assembly is positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) a pumping chamberbetween the inlet and outlet and configured to be compressed anddecompressed to pump fluid, (iv) a first one-way valve positioned on afirst side of the pumping chamber, (v) a second one-way valve positionedon a second side of the pumping chamber, and (vi) an adjustable inletlock configured to selectively prevent fluid movement through the inlet,and wherein the tube is configured to extend from the inlet of the valveassembly to the person's body cavity. The method includes, while theadjustable inlet lock is in a locked position, an external portion ofthe fluid-management system attaching to a body of the person. Themethod further includes, while the adjustable inlet lock is in anunlocked position, (i) the pumping chamber compressing anddecompressing, so as to provide a pumping action to prime thefluid-management system and get fluid moving through thefluid-management system and (ii) after the fluid-management system isprimed, the fluid-management system siphoning fluid from the body cavitythrough the fluid-management system.

One of ordinary skill in the art will appreciate these as well asnumerous other aspects in reading the following disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an example fluid-management system, according to anexample of the present disclosure.

FIG. 1B illustrates the example fluid-management system of FIG. 1Aimplanted in a person.

FIG. 2A illustrates a cross-sectional schematic view of a one-way valvein a closed state.

FIG. 2B illustrates a cross-sectional schematic view of a one-way valvein an open state.

FIG. 3 shows representative pleural pressures as they change duringinspiration and expiration.

FIG. 4A illustrates an example fluid-management system, according to anexample embodiment.

FIG. 4B illustrates the example fluid-management system of FIG. 4Aimplanted in a person.

FIGS. 5A-D illustrates a pumping chamber of the fluid-management systemof FIG. 4A at various stages of compression and decompression.

FIGS. 6A-B illustrate an example adjustable outlet lock, according to anexample of the present disclosure.

FIGS. 7A-B illustrate an example adjustable outlet lock, according to anexample of the present disclosure.

FIGS. 8A-D illustrate an example adjustable outlet lock, according to anexample of the present disclosure.

FIGS. 9A-C illustrate an example adjustable outlet lock, according to anexample of the present disclosure.

FIGS. 10A-B illustrate an example adjustable outlet lock, according toan example of the present disclosure.

FIGS. 11A-B illustrate an example adjustable outlet lock, according toan example of the present disclosure.

FIGS. 12A-B illustrate an example adjustable outlet lock, according toan example of the present disclosure.

FIG. 13 illustrates an example arrangement of an external portion of afluid-management system, according to an example of the presentdisclosure.

FIG. 14 illustrates an example arrangement of an external portion of afluid-management system, according to an example of the presentdisclosure.

FIG. 15A illustrates an example fluid-management system, according to anexample of the present disclosure.

FIG. 15B illustrates an example arrangement of an external portion ofthe fluid-management system of FIG. 15A, according to an example of thepresent disclosure.

FIG. 16 illustrates an example process for connecting an examplefluid-management system to an implanted tube, according to an example ofthe present disclosure.

FIG. 17 illustrates an example process for connecting an examplefluid-management system to an implanted tube, according to an example ofthe present disclosure.

FIG. 18 shows an example method fluid management, according to anexample of the present disclosure.

FIG. 19 shows an example method of draining fluid from a body cavity ofa person to a reservoir external to the person's body, according to anexample of the present disclosure.

FIG. 20 shows an example method of draining fluid from a body cavity ofa person to a reservoir external to the person's body, according to anexample of the present disclosure.

FIG. 21A illustrates an example fluid-management system, according to anexample of the present disclosure.

FIG. 21B illustrates a cross-sectional view of a valve assembly of theexample fluid-management system of FIG. 21A with an adjustable inletlock in a locked position, according to an example of the presentdisclosure.

FIG. 21C illustrates a cross-sectional view of a valve assembly of theexample fluid-management system of FIG. 21A with an adjustable inletlock in an unlocked position, according to an example of the presentdisclosure.

FIG. 21D illustrates the example fluid-management system of FIG. 21Aimplanted in a person.

FIGS. 22A-D illustrates a pumping chamber of the fluid-management systemof FIG. 21A at various stages of compression and decompression,according to an example of the present disclosure.

FIGS. 23A-B illustrates the fluid-management system of FIG. 21A atvarious stages of compression and decompression of the pumping chamber,according to an example of the present disclosure.

FIGS. 24A-D illustrate various stages of operation of the examplefluid-management system of FIG. 21A, according to an example of thepresent disclosure.

FIG. 25A illustrates an example fluid-management system, according to anexample of the present disclosure.

FIG. 25B illustrates a cross-sectional view of a valve assembly of theexample fluid-management system of FIG. 25A with an adjustable inletlock in a locked position and an adjustable outlet lock in a lockedposition, according to an example of the present disclosure.

FIG. 25C illustrates a cross-sectional view of a valve assembly of theexample fluid-management system of FIG. 25A with an adjustable inletlock in an unlocked position and an adjustable outlet lock in anunlocked position, according to an example of the present disclosure.

FIG. 25D illustrates the example fluid-management system of FIG. 25Aimplanted in a person.

FIGS. 26A-E illustrate various stages of operation of the examplefluid-management system of FIG. 25A, according to an example of thepresent disclosure.

FIG. 27 illustrates an example pumping chamber, according to an exampleof the present disclosure.

FIG. 28A illustrates an example pumping chamber, according to an exampleof the present disclosure.

FIG. 28B illustrates a cross-sectional view of the example pumpingchamber of FIG. 28A taken along line A-A, according to an example of thepresent disclosure.

FIG. 29A illustrates an example pumping chamber, according to an exampleof the present disclosure.

FIG. 29B illustrates a cross-sectional view of the example pumpingchamber of FIG. 29A taken along line B-B, according to an example of thepresent disclosure.

FIG. 30 illustrates an example valve assembly, according to an exampleof the present disclosure.

FIG. 31A illustrates a cross sectional view of the pumping chamberaccess port of the example valve assembly of FIG. 30 , according to anexample of the present disclosure.

FIG. 31B illustrates a cross sectional view of the inlet access port ofthe example valve assembly of FIG. 30 , according to an example of thepresent disclosure.

FIG. 32A illustrate an example valve assembly having an inlet accessport that is inaccessible and hidden from view when an adjustable inletlock is in the locked position, according to an example of the presentdisclosure.

FIG. 32B illustrates the example valve assembly when the adjustableinlet lock is in the unlocked position and the inlet access port isaccessible, according to an example of the present disclosure.

FIGS. 33A-B illustrate an example valve assembly draining into a bottle,according to an example of the present disclosure.

FIG. 34A illustrates an example valve assembly, according to an exampleof the present disclosure.

FIG. 34B illustrates a cross sectional view of a body of the pumpingchamber of the example valve assembly of FIG. 34A, according to anexample of the present disclosure.

FIG. 35A illustrates an example valve assembly configured to attach toan external tube, according to an example of the present disclosure.

FIG. 35B illustrates the example valve assembly of FIG. 35A attached toan external tube, according to an example of the present disclosure.

FIG. 36A illustrates an example one-way valve, according to an exampleof the present disclosure.

FIG. 36B illustrates the example one-way valve of FIG. 36A in a dry orsubstantially dry condition, according to an example of the presentdisclosure.

FIG. 36C illustrates the example one-way valve of FIG. 36A in a wet orpartially wet condition, according to an example of the presentdisclosure.

FIG. 36D illustrates the example one-way valve of FIG. 36A in a fullywetted condition, according to an example of the present disclosure.

FIG. 37 shows an example fluid-management method, according to anexample of the present disclosure.

FIG. 38 shows an example method of draining fluid from a body cavity ofa person to a reservoir external to the person's body, according to anexample of the present disclosure.

FIG. 39 shows an example method of draining fluid from a body cavity ofa person to a reservoir external to the person's body, according to anexample of the present disclosure.

FIG. 40 illustrates an example valve assembly, according to an exampleof the present disclosure.

FIG. 41 illustrates an example adjustable tube lock, according to anexample of the present disclosure.

FIG. 42A illustrates an example valve assembly having an adjustableoutlet lock in a closed position, according to an example of the presentdisclosure.

FIG. 42B illustrates the example valve assembly of FIG. 42A with theadjustable outlet lock in an open position, according to an example ofthe present disclosure.

FIG. 43A illustrates an example valve assembly having an adjustableoutlet lock in a closed position, according to an example of the presentdisclosure.

FIG. 43B illustrates the example adjustable outlet lock of FIG. 43A inan open position, according to an example of the present disclosure.

FIG. 44 illustrates an example valve assembly configured to attach to aplurality of adapters, according to an example of the presentdisclosure.

FIG. 45A illustrates an example pumping chamber, according to an exampleof the present disclosure.

FIG. 45B illustrates a cross-sectional view of a portion of the examplepumping chamber of FIG. 45A, according to an example of the presentdisclosure.

FIG. 45C illustrates a cross-sectional view of a portion of the examplepumping chamber of FIG. 45A when a portion of the pumping chamber iscompressed, according to an example of the present disclosure.

DETAILED DESCRIPTION

The following disclosure makes reference to the accompanying figures andseveral example embodiments. One of ordinary skill in the art shouldunderstand that such references are for the purpose of explanation onlyand are therefore not meant to be limiting. Part or all of the disclosedsystems, devices, and methods may be rearranged, combined, added to,and/or removed in a variety of manners, each of which is contemplatedherein.

As mentioned above, current fluid-management systems and methods thatallow a person to selectively control when to drain excess fluid from abody cavity such that such that an external reservoir is not alwaysattached to the implanted tube that is in fluid communication with thebody cavity have numerous drawbacks. The fluid-management methods andsystems in accordance with the present disclosure beneficially provideimproved methods and systems for draining fluid from a body cavity to anexternal reservoir. In particular, the methods and systems in accordancewith the present disclosure beneficially provide for avoiding a need toattach a dedicated pump-and-reservoir assembly that includes an activepumping component for pumping fluid out of the body cavity and adrainage reservoir for collecting the pumped fluid. Rather, inaccordance with the present disclosure, the components to initiatedraining safely and effectively are on the person at all times, suchthat the person can selectively drain the body cavity.

In one example, a fluid-management system for selectively draining fluidfrom a body cavity includes a valve assembly and a tube for carryingfluid from a body cavity of a person to the valve assembly. The valveassembly is configured to be positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) one or more one-wayvalves positioned between the inlet and outlet that are each configuredto open and close based on fluctuations in pressure between the person'sbody cavity and the one-way valve, and (iv) an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet. Thefluid-management system may be used by a person to drain fluid into anyappropriate external reservoir. Body fluid to be drained may compriseliquid, gas, or a combination of liquid and gas.

Turning now to the figures, FIG. 1A depicts an example fluid-managementsystem 100, and FIG. 1B depicts the fluid-management system 100implanted in a person's body 102. Fluid-management system 100 includes avalve assembly 104 having an inlet 106, an outlet 108, a one-way valve110, and an adjustable outlet lock 112. One-way valve 110 is positionedbetween inlet 106 and outlet 108 and is configured to open and closebased on fluctuations in pressure between cavity 114 and one-way valve110. Fluid-management system 100 also includes a fluid-management tube116 for carrying fluid from cavity 114 to valve assembly 104. Tube 116is configured to extend from inlet 106 to cavity 114 and allow movementof fluid from cavity 114 to inlet 106 of valve assembly 104. Tube 116 isimplanted in person's body 102, such that a proximal end 118 of tube 116is positioned within cavity 114 and a distal end 120 of tube 116 ispositioned external to body 102. Further, valve assembly 104 ispositioned external to the person's body 102. In particular, withreference to FIG. 1A, external portion 117 of fluid-management system100 is positioned external to person's body 102. Further, in the exampleillustrated, the internal portion of fluid-management system 100includes a first portion 119 of tube 116 positioned behind the ribs andwithin cavity 114, a second portion 121 of tube 116 positioned in frontof the ribs within person's body 102. Other example arrangements of theinner and external portions of fluid-management system 100 are possibleas well.

One-way valve 110 includes a one-way valve frame 130 enclosing andproviding structure and support to one-way valve 110. Further, one-wayvalve frame 130 may also serve to connect to distal end 120 of tube 116.The size and shape of the one-way valve frame 130 can be designed toprovide joining points or interconnectable joints to tube 116. In anexample, valve assembly 104 is non-removably attached to tube 116. Asused herein, the term “non-removably attached” means that a firstcomponent (e.g., the valve assembly) is intended not to be removed froma second component (e.g., the tube) during normal use and cannot bereadily removed from the second component without the use ofextraordinary force and/or tools.

Cavity 114 may be a cavity in person's body 102 that may build up fluidfor which there is a desire or need to selectively drain out of thebody. In the example of FIG. 1A, cavity 114 is a pleural cavity ofperson's body 102. However, other body cavities are possible, such as aperitoneal cavity, a cerebrospinal cavity, a pericardial cavity, abreast cavity, or a cavity of a cystic lesion, among otherpossibilities.

Adjustable outlet lock 112 is configured to selectively prevent fluidmovement through outlet 108. In particular, adjustable outlet lock 112is configured to move between a locked position in which adjustableoutlet lock 112 seals outlet 108 and an unlocked position in which theadjustable outlet lock 112 allows fluid movement through outlet 108.Adjustable outlet lock 112 may be controlled by a person such that theperson may keep adjustable outlet lock 112 in the locked position whennot draining cavity 114. Further, the person may switch adjustableoutlet lock 112 to the unlocked position when the person wishes to draincavity 114.

In the example of FIG. 1A, adjustable outlet lock 112 is located atoutlet 108 and is configured to cover outlet 108 when in the lockedposition. However, adjustable outlet lock 112 may be located in otherpositions, such as upstream of outlet 108. Further, in the example ofFIG. 1A, adjustable outlet lock 112 takes the form of a cap and islocked by securely attaching the cap to outlet 108. In particular, thelocked position of the cap corresponds to the cap being attached tooutlet 108 (as seen in FIG. 1B), and the unlocked position correspondsto the cap being unattached from outlet 108 (as seen in FIG. 1A). Otheradjustable outlet locks are possible, some examples of which aredescribed in greater detail below.

As mentioned above, one-way valve 110 is configured to open and closebased on fluctuations in pressure between cavity 114 of person's body112 and one-way valve 110. By opening and closing based on fluctuationsin pressure between cavity 114 and one-way valve 110, one-way valve 110is able to allow fluid movement out of outlet 108 and also preventretrograde flow (also referred to herein as “backflow”) influid-management system 100 (e.g., flow of liquid and/or air back intotube 116). In practice, retrograde flow may result in aspiration of airback into cavity 114 (e.g., a pleural cavity) or flow of liquid backinto the cavity 114, and such retrograde flow could cause various issuessuch as infection and/or collapse of the lung. Therefore, preventingbackflow may help to avoid such issues that may be associated with flowof liquid and/or air back into tube 116. Further, in some examples,opening and closing of one-way valve 110 may also provide a pumpingaction that helps move fluid from cavity 114 and through tube 116 andvalve assembly 104.

Opening and closing of one-way valve 110 is generally described withrespect to FIGS. 2 a-b . FIG. 2 a shows one-way valve 110 in a closedstate, whereas FIG. 2 b shows one-way valve 110 in an open state. Whenone-way valve 110 is in a closed position as shown in FIG. 2 a , thepressure differential across valve 110 is such that P₁≤P₂+P_(C), whereP₁ is the pressure on a first side 132 of one-way valve 110, P₂ is thepressure on a second side 134 of one-way valve 110, and P_(C) is thecracking pressure of one-way valve 110. Similarly, when one-way valve110 is in an open position as shown in FIG. 2 b , the pressuredifferential across valve 110 is such that P₁>P₂+P_(C), where P₁ is thepressure on first side 132 of one-way valve 110, P₂ is the pressure onsecond side 134 of one-way valve 110, and P_(C) is the cracking pressureof one-way valve 110. In this instance, with P₁>P₂+P_(C), fluid wouldflow from first side 132 through one-way valve 110 to second side 134.

In an example, one-way valve 110 may be configured to have a lowcracking pressure, such that the one-way valve is configured totransition from a closed state to an open state with relatively smalldifferential pressures across the one-way valve. For instance, thecracking pressure of one-way valve 110 can range anywhere from about 25cmH₂O or less to about 5 cmH₂O or less, and as specific examples, thecracking pressure of a given one-way valve could be less than about 25cmH₂O, less than about 15 cmH₂O, less than about 10 cmH₂O, or less thanabout 5 cmH₂O. Further, in an example, one-way valve 110 may beconfigured to have a low resealing pressure, such that the one-way valveis configured to transition from an open state to a closed state withsmall differential pressures across the one-way valve. For instance, theresealing pressure of one-way valve 110 can range anywhere from about 15cmH₂O or less to about 2 cmH₂O or less, and as specific examples, thecracking pressure of a given one-way valve could be less than about 15cmH₂O, less than about 10 cmH₂O, less than about 5 cmH₂O, or less thanabout 2 cmH₂O.

Further yet, the cracking pressure and/or the resealing pressure forone-way valve 110 may be selected based on any of various factors, anexample of which may be the type of cavity from which thefluid-management system is intended to drain fluid, among otherexamples. For instance, as one possibility, in situations wherepressures vary from low positive to low negative (e.g., pleural cavity),the cracking pressure and/or the resealing pressure may be kept lowerthan in situations in which pressures tend to remain positive (e.g.,peritoneal cavity). As another possibility, in situations wherepressures in a cavity tend to remain positive but it is desired to notlet fluid volume drop to zero, the valve cracking pressure may beselected at a level configured to keep fluid in the cavity. For example,for the cerebospinal cavity, the cerebospinal cavity tends to remainpositive pressure but it is desirable to not let cerebrospinal fluid(CSF) drop to zero. Thus, for the cerebospinal cavity, the valvecracking pressure may be set to a desirable level that will keep thefluid pressure in that space from dropping below the desired crackingpressure and would keep CSF in the cerebospinal cavity.

In an example, one-way valve 110 may include a plurality of lips thatdefine a slit that can move from a closed position to an open position.For instance, with reference to FIGS. 2A-B, one-way valve 110 mayinclude first lip 202 and second lip 204 that define slit 206. The lips202 and 204 may be configured such that, when the lips are in the closedposition, the surface area of interaction between the lips is relativelysmall. For instance, in an example, the surface area of interaction isbelow 60 mm² and preferably in a range 0.6 mm² to 6 mm². A surface areain this range may help ensure that the one-way valve works well bothwhen wet and dry. As the surface area of interaction of valve lipsbecomes large (e.g., larger than 60 mm²), significant cohesive andadhesive forces may develop between the liquid and the two surfaces whenthe lips are wetted, thereby making it more difficult for the valve toopen. This force required to separate the two surfaces of the valve lipsis given by the relationship,

${F = \frac{2 \cdot T \cdot A}{h}},$

where F=the force required to separate the lips, T is the surfacetension of the wetting liquid (T=70 for water at 37° C.), A is the areaof the interface between the lips and h is the thickness of the liquidlayer between the lips.

In the example of FIGS. 2A-2B, one-way valve 110 is formed as a duckbillvalve. However, other types and/or shapes of valves are possible aswell, including, for instance, a flapper valve and a cross-slit valve,among other possibilities.

Further, in an example, one-way valve 110 is configured such that, whenin the open state, the opening is larger than the lumen of tube 116.Such a configuration may help to ensure that any debris that can getinto the tube can clear through the valve. In some examples, the openingat proximal end 118 of tube 116 is smaller than the lumen of tube 116,the lumen of tube 116 is smaller than the opening of one-way valve 110when it is in the open state, and the opening of one-way valve 110 whenit is in the open state in turn is smaller than the lumen of outlet 108.Other examples are possible as well.

In operation of fluid-management system 100, fluctuations in pressurebetween cavity 114 and one-way valve 110 may cause one-way valve 110 toopen and close. In one example, the fluctuations in pressure betweencavity 114 and one-way valve 110 occur based on respiratory action of abreathing cycle of the person. For instance, when cavity 114 is thepleural cavity, pressure between cavity 114 and one-way valve 110 swingsfrom positive to negative during the breathing cycle. FIG. 3 illustratesan example pressure fluctuation that may occur between cavity 114 andone-way valve 110 during a breathing cycle. Pressures in the pleuralcavity are not static and typically vary during normal breathing. Asseen in FIG. 3 , pleural pressure (P_(pleural)) 300 relative toatmospheric pressure swings from slightly negative during inspiration toslightly positive during expiration. During inspiration, externalintercostal muscles contract leading to elevation of the ribs andsternum, and the diaphragm contracts, flattening out and pressing downon the abdominal contents. This combined action leads to an expansion ofthe thoracic cavity with a decrease in the pleural pressure that expandsthe elastic lung. Expiration during normal breathing is largely apassive process relying on elastic recoil. During expiration, theexternal intercostal muscles and the diaphragm simply relax. Withrelaxation of the external intercostals, the elasticity of the inflatedlungs causes them to recoil back to their original position. This actionleads to a decrease in size of the thoracic cavity with an increase inthe pleural pressure.

The fluctuations in pleural pressure can be accentuated in somesituations, such as situations where a person is breathing deeply and/orcoughing. Based on these fluctuations in pressure between cavity 114 andone-way valve 110, one-way valve 110 will close during inspiration (whenpressure is negative) and one-way valve 110 will open during expiration(when pressure is positive). As such, the valve assembly 104 provides apump action with energy provided by the respiratory action of the persondraining fluid from cavity 114 such that one-way valve 110 can allowflow of fluid from cavity 114 to outside during expiration and preventbackflow during inspiration. In particular, given this opening andclosing due to respiratory action, valve assembly 104 can act as a pumpto move fluid from cavity 114, through tube 116, through one-way valve110, and out outlet 108. Further, since the pleural cavity istransiently moving positive to negative in pressure, one-way valve 110also prevents backflow as valve assembly 104 provides the pumpingaction. When a person breathes in, one-way valve 110 closes and thusacts as check valve to prevent fluid and/or air from entering tube 116.On the other hand, when a person breathes out, the pleural pressureincreases and forces fluid to move forward.

An example draining process for draining body cavity 114 is describedbelow. Prior to draining body cavity 114 using fluid-management system100, a person may first select an external reservoir in which to drainthe fluid from cavity 114. In general, the person may drain the fluidinto any appropriate reservoir such as a sink, a commode, and/or acontainer provided by the person, among other possibilities. Further,prior to initiating drainage, the valve assembly area may be cleanedwith soap and water and/or decontaminated with alcohol, betadine, orchlorhexidine, among other possibilities. Next, to initiate the drainingprocess, the person may switch adjustable outlet lock 112 to theunlocked position. When adjustable outlet lock 112 is in the unlockedposition, fluid may begin moving through fluid-management system 100. Asdescribed above, one-way valve 110 may open and close based onfluctuations in the pressure between cavity 114 and one-way valve 110.In practice, when adjustable outlet lock 112 is in the locked position,the one-way valve 110 is typically closed since typically P₁≤P₂+P_(C).

Upon initially unlocking the adjustable outlet lock 112, fluid may beginmoving through fluid-management system 100 due to the pressure of bodycavity 114 and/or the pumping action provided by the opening and closingof one-way valve 110. This will move fluid from cavity 114, through tube116, through one-way valve 110, and then out of outlet 108 and into theexternal reservoir selected by the person. After the draining processhas begun, the person may drain the fluid from cavity 114 until cavity114 is empty and/or a desired amount of fluid has been drained fromcavity 114. Finally, after draining is complete, the person may clean ordecontaminate outlet 108 and/or adjustable outlet lock 112 and switchadjustable outlet lock 112 into the locked position.

Fluid-management system 100 may also be designed such that, when asufficient amount of fluid has moved through fluid-management system100, a siphon effect can be utilized to help to more quickly drain thefluid from cavity 114. For instance, fluid-management system 100 may bedesigned such that the pressure of cavity 114 and/or pumping actionprovided by valve assembly 104 may allow a column of fluid to formwithin the tube that in turn leads to a siphon effect. In other words,fluid-management system 100 may be designed such that, once tube 116 isprimed by valve assembly 104 (e.g., based on the respiratory action),fluid from cavity 114 can be siphoned out.

Fluid-management system 100 may allow fluid from cavity 114 to besiphoned out when conditions suitable for siphoning occur. In general,siphoning may occur when (i) tube 116 has a sufficient column of fluidin tube 116 and (ii) the end of the column of fluid is lower than thefluid level in cavity 114, which provides a sufficient hydrostaticpressure gradient.

During draining, a person may control the level of outlet 108 in orderto facilitate the end of the column of fluid being lower than the fluidlevel in cavity 114. Ensuring that the tube is held a sufficient amountbelow the fluid level may facilitate siphoning during the drainingprocess.

The column of fluid needed to generate a siphon effect may vary. Withinexamples, a sufficient column of fluid may be a column of fluid having alength within the range of 10-100 centimeters (cm). Further, a longertube may provide a longer column of fluid, which in turn may provide astronger siphon effect and thus provide a quicker flow of fluid to morequickly drain fluid from cavity 114. In an example, after siphoningbegins during a draining process, the person may continue draining fluidfrom cavity 114 until the cavity 114 is empty and/or a desired amount offluid is removed from cavity 114. When siphoning is taking place,one-way valve 110 remains open. Finally, after draining is complete, theperson may clean and/or decontaminate outlet 108 and/or adjustableoutlet lock 112 of valve assembly 104 and move adjustable outlet lock112 into the locked position. In some examples, the one-way valves,tubing diameter, and/or tubing length can be selected so as to ensure adesired minimum flow rate, such as 25 milliliters per minute (ml/min),50 ml/min, 75 ml/min, 100 ml/min, 150 ml/min or greater, among otherpossibilities. Additionally or alternatively, the one-way valves (andassociated cracking pressures), tubing length, and/or tubing diametercan be selected to prevent the pressure in the fluid cavity droppingbelow a desired level, such as −10 cmH₂O, −20 cmH₂O, −30 cmH₂O, or −40cmH₂O or more negative, among other possibilities. In an example, forthe pleural space, persons can have pain when the pressure is too low,have coughing fits, and there are reports of “reexpansion pulmonaryedema” occurring when large volumes are drained and/or the pressure istoo low. Preventing the pressure in the fluid cavity from dropping belowa desired level may help to avoid or reduce such issues.

In some examples, the cavity pressure of the cavity being drained maytend to remain positive rather than fluctuate from positive to negativebased on respiratory action of a person's breathing cycle. For instance,peritoneal cavity pressure relative to atmospheric pressure tends toremain positive throughout the breathing cycle. As such, in an examplewhere the body cavity being drained is the peritoneal cavity, thepressure between cavity 114 and one-way valve 110 may tend to remainpositive. In such a case, one-way valve 110 may not routinely open andclose to provide a pump action to move fluid through the tube 116.Rather, in such a case, when adjustable outlet lock 112 is switched tothe unlocked position, the positive peritoneal-cavity pressure may tendto cause fluid to move forward throughout the tube and to keep one-wayvalve 110 open. However, in situations where the cavity pressure maytend to remain positive, fluctuations in pressure may still occur forvarious reasons that may cause one-way valve 110 to close. For instance,the cavity pressure may, for one reason or another, fluctuate tonegative. As one possibility, if the body position and/or tip of tube116 were positioned to be such that the abdomen was lower than the tubeoutlet, the pressure could drop to negative. As another possibility, ifthe space (e.g., peritoneal space) was diseased such that thebowel/abdominal wall could not expand/shift as fluid is drained, anegative pressure could generate. As yet another possibility, a largerelease of gas (volume shift) from the abdomen could transientlytransition pressure to negative. Other examples are possible as well. Insuch a case where the cavity pressure may tend to remain positive butfluctuations in pressure may still occur for various reasons that maycause one-way valve 110 to close, rather than providing a pumping actionduring the draining process, one-way valve 110 may instead serveprimarily as a backstop to ensure that, if pressure fluctuates duringthe draining process to a negative pressure for some reason, one-wayvalve 110 closes to prevent backflow.

In the examples discussed above, the valve assembly 104 includes asingle one-way valve. In other examples, the valve assembly 104 includestwo one-way valves arranged in series, and the two one-way valves mayallow for additional capabilities and/or benefits relative to a valveassembly having a single one-way valve. An example fluid-managementsystem including a valve assembly having two one-way valves is describedfurther with reference to FIGS. 4A-B.

FIG. 4A depicts an example fluid-management system 100′ and FIG. 4Bdepicts the fluid-management system 100′ implanted in a person's body102. Fluid-management system 100′ includes a valve assembly 104′ havingan inlet 106, and outlet 108, one-way valves 110′ and 110″, and anadjustable outlet lock 112. One-way valves 110′ and 110″ are arranged inseries and are housed in a pumping chamber 402 or on the proximal anddistal ends of pumping chamber 402. One-way valves 110′ and 110″ arepositioned between inlet 106 and outlet 108 and are each configured toopen and close based on fluctuations in pressure between cavity 114 andthe one-way valve. Further, one-way valve 110′ is configured to open andclose based on changes in cavity 114 pressure and pressure on an inside403 of chamber 402, and one-way valve 110″ is configured to open andclose based on changes in pressure on inside 403 of chamber 402 (whichmay change based on cavity pressure and opening of one-way valve 110′)and atmospheric pressure. Fluid-management system 100′ also includes afluid-management tube 116 for carrying fluid from cavity 114 to valveassembly 104′. Tube 116 is configured to extend from inlet 106 to cavity114 and allow movement of fluid from cavity 114 to inlet 106 of valveassembly 104′. Tube 116 is implanted in person's body 102, such that aproximal end 118 of tube 116 is positioned within cavity 114 and adistal end 120 is positioned external to body 102. Further, valveassembly 104′ is positioned external to the person's body 102.

As mentioned above, the one-way valves 110′ and 110″ are arranged inseries and are housed in pumping chamber 402 or on the proximal anddistal ends of pumping chamber 402. In an example, the main body 404 ofpumping chamber may form and/or house one-way valve frames 130′ and130″, which enclose and provide structure and support to one-way valves110′ and 110″, respectively. In the example of FIG. 4A, the one-wayvalve frame 130′ is integral with tube 116. In other examples, one-wayvalve frame 130′ may serve to connect to distal end 120 of tube 116(e.g., in a similar fashion as illustrated in FIG. 1A). The size andshape of the one-way valve frame 130′ can be designed to provide joiningpoints or interconnectable joints to tube 116. In an example, valveassembly 104′ is non-removably attached to tube 116.

The valve assembly 104′ may operate is a similar fashion as the valveassembly 104 described with respect to FIGS. 1-3 . Furthermore, valveassembly 104′ provides some additional capabilities for draining fluidfrom cavity 114. For instance, valve assembly 104′ may provideadditional capabilities and/or benefits relative to a valve assemblyhaving a single one-way valve, including but not limited to improvingthe flow of fluid movement in the fluid-management system and/orproviding an additional barrier to retrograde flow, among otherpossibilities.

Turning first to operating in a similar fashion as valve assembly 104,each of valves 110′ and 110″ may operate in the same fashion and havethe same properties as one-way valve 110 of FIG. 1A. For instance,one-way valves 110′ and 110″ are each configured to open and close basedon fluctuations in pressure between a cavity of a person's body and theone-way valve. As one example, fluctuations in pressure (e.g.,fluctuations that occur based on respiratory action of a breathing cycleof the person) between cavity 114 and one-way valves 110′ and 110″ maycause one-way valves 110′ and 110″ to open and close, thereby providinga pumping action to move fluid. Given that one-way valves 110′ and 110″are the same or similar in many respects to one-way-valve 110, one-wayvalves 110′ and 110″ thus are not described in as great of detail. Itshould be understood, however, that any of the possibilities andpermutations described with respect to one-way valve 110 are alsopossible with respect to one-way valves 110′ and 110″.

Turning next to the additional capability of creating fluid movement inthe fluid-management system 100′, the pumping chamber 402 of valveassembly 104′ can be used to prime the system and get fluid movingthrough fluid-management system 100′. Such a two-valve configuration mayallow a person to prime the fluid-management system, which may help tospeed up the draining process by getting fluid to move more quicklythrough the fluid-management system, which in turn may get the siphoneffect to occur more quickly.

Such priming of fluid-management system 100′ may be useful in varioussituations. For example, such priming of the system may be useful if thepumping action provided by the respiratory action is not sufficient toget fluid moving and/or does not get fluid moving as quickly as a persondesires. As another example, such priming of the system may be useful ifthere is low positive pressure between cavity 114 and one-way valves110′, 110″ that is insufficient to get fluid moving and/or does not getfluid moving as quickly as a person desires. As yet another example,such priming of the system may be useful if for some reason air is inthe tube. In tubes common in catheter applications, a small amount ofair can generate enough surface tension to air lock the tube. Priming offluid-management system 100′ may help overcome such generated airlocks.As still yet another example, such priming of fluid-management system100′ may be useful if there is not a sufficient hydrostatic pressuregradient to provide for a siphon effect. Other examples are possible aswell.

Such a two-valve configuration may also allow for the generation ofsupraphysiologic pressures (both positive by compressing and negative bydesign of the resilience of the pump chamber 402) that may also be ofbenefit to clear potential obstructions and/or debris from thefluid-management system 100′ (e.g., within the tubing, from within theone-way valves, or from within other regions of the valve assembly104′).

Priming of fluid-management system 100′ using pumping chamber 402 isdescribed further with respect to FIGS. 5A-D. FIG. 5A shows across-sectional schematic view of valve assembly 104′ in a generally orsubstantially non-compressed state with both one-way valve 110′ andone-way valve 110″ closed. For clarity, one-way valve 110′ is alsoreferred to herein as an “inlet one-way valve,” and one-way valve 110″is referred to as an “outlet one-way valve.” Inlet one-way valve 110′ ispositioned on a first side 501 of pumping chamber 402 proximate to theinlet of valve assembly 104′ and outlet one-way valve 110″ is positionedon a second side 503 of pumping chamber 402 proximate to outlet 108 ofvalve assembly 104.

FIG. 5B shows a cross-sectional schematic view of valve assembly 104′ ina generally or substantially compressed state. In an example, as shown,a first force 502 may act on a first wall 504 causing first wall 504 tocollapse in towards interior space 506. Correspondingly, a second force508 may additionally or alternatively act on a second wall 510 causingsecond wall 510 to collapse in towards interior space 506.

First force 502 and second force 508 may be applied to pumping chamber402 in any suitable fashion. As one possibility, a person usingfluid-management system 100′ may supply the forces by manuallycompressing pumping chamber with their fingers. As another possibility,valve-system 104′ may include an electromechanical actuator configuredto apply forces 502 and 508. For instance, valve assembly 104′ mayinclude a piezoelectric diaphragm connected to the body of pumpingchamber 402. The piezoelectric diaphragm may be activated andinactivated by a controller, and both the piezoelectric diaphragm 540and the controller 530 may be powered, e.g., by a battery. As anotherexample, valve assembly 104′ may include a piston or cam configured toapply forces 502 and 508 to pumping chamber 402. Other example methodsand systems for applying forces 502 and 508 are possible as well.

The collapse of the first wall 504 and/or second wall 510 serves todecrease the volume of interior space 506 and to increase the pressurein interior space 506. This increase in pressure causes inlet one-wayvalve 110′ to remain closed and causes outlet one-way valve 110″ toopen, and fluid located in interior space 506 to flow from interiorspace 506 through outlet one-way valve 110″ and out outlet 108. Forincompressible fluids, the change of volume experienced by interiorspace 506 in response to the collapse of first wall 504 and/or secondwall 510 will be approximately equal to the volume of fluid that movesfrom interior space 506 through outlet one-way valve 110″. As the fluidmoves from interior space 506 through outlet one-way valve 110″, thepressure in interior space 506 will decrease. Once the interior pressureequals or substantially equals the pressure in outlet 108, flow willstop and outlet one-way valve 110″ will close as shown in FIG. 5C.

As described above, the body of pumping-chamber 402 may be substantiallyresiliently flexible and therefore, after being placed in a compressedstate as shown in FIGS. 5B and 5C, valve assembly 104′ will return to anuncompressed state as shown in FIG. 5D when at least one of the firstforce 502 and the second force 508 are removed. As the first wall 504returns to its uncompressed state as the first force 502 is removedand/or the second wall 510 returns to its uncompressed state as thesecond force 508 is removed, the volume of the interior space 506increases and the pressure in the interior space 506 decreases. Thepressure inside the interior space 506 eventually drops below thepressure on the inlet 501 near inlet one-way valve 110′ and causes inletone-way valve 110′ to open and fluid located in the inlet to flow intothe interior space 506. In this way, valve assembly 104′ operates as apump that, generally, draws fluid from inlet 501 and passes it to outlet108.

In some examples, pumping chamber 402 may be made of material thatallows for pumping chamber 402 to be compressed and then freely returnedto its original state. Pumping chamber 402 may be made of any suitablematerial. For example, pumping chamber 402 may be a resiliently flexibletube or cylinder made of polyurethane, silicone, polyvinyl chloride, orlatex rubber. Alternatively, pumping chamber 402 may be made of acombination of two or more materials where at least one of the componentmaterials provides resilience and at least one of the componentmaterials provides fluid containment. For example, pumping chamber 402may be composed of an elastic nitinol, steel, polyester, or otherelastic component to provide for resiliency and a second fluidcontainment component such as polyurethane, silicone, polyvinylchloride, latex rubber, polyethylene terephthalate, nylon,polytetrafluoroethylene, PEBAX, or the like to provide fluid containmentwithin pumping chamber 402. In other examples, such as examples wherevalve assembly 104′ includes an electromechanical actuator (e.g., apiezoelectric diaphragm, piston, or cam configured to apply forces 502and 508 to pumping chamber 402), the material may be flexible but notresilient (or having limited resilience), as an electromechanicalactuator may provide both active compression and active rarefication.

Turning next to the additional barrier to retrograde flow, the additionof the second one-way valve provides another barrier to retrograde flow.In the example a FIG. 1A, one-way valve 110 provides a barrier toretrograde flow, whereas in the example of FIG. 4 a , each of one-wayvalves 110′ and 110″ provide a barrier to retrograde flow. Thisadditional barrier to retrograde flow may provide increased protectionagainst retrograde flow.

In order to prevent blocking or clogging of the disclosedfluid-management system, one or more components of the fluid-managementsystem may be coated in anticoagulation factors or fibrinolytic factors.For example, the components or surfaces of valve assemblies 104, 104′and/or implanted tube 116 may be coated at least in part withanticoagulation factors or fibrinolytic factors. For instance, withreference to FIG. 1A, internal portions of a body 140 of valve assembly104, one-way valve 110, and/or internal portions of tube 116 may becoated in anticoagulation factors or fibrinolytic factors. Further, withreference to FIG. 4A, internal portions of pumping chamber 402, one-wayvalves 110′ and 110″, and/or internal portions of tube 116 may be coatedin anticoagulation factors or fibrinolytic factors. Other components maybe coated with anticoagulation factors or fibrinolytic factors as well.

The presence of the anticoagulation factors may reduce the amount ofclotting that would otherwise occur if they were not present. Examplesof anticoagulation factors include heparin, low molecular weightheparin, fondaparinux, idraparinux, idrabiotaparinux, diabigatran,rivaroxaban, apixan, betrixaban, edoxaban, darexaban, letaxaban,eribaxaban, hirudin, lepirudin, bivalirudin, argatroban, dabigatran,ximelagatran, hementin, vitamin E, coumarin, warfarin, acenocoumarol,phenprocoumon, atromentin, phenindione, brodifacoum, and difenacoum.Examples of fibrinolytic factors include plasmin, tissue plasminogenactivator, urokinase, streptokinase, plasminogen activator inhibitor-1inhibitor, and plasminogen activator inhibitor-2 inhibitor. Otherexamples of anticoagulation factors or fibrinolytics may be used.

In at least some implementations of the valve assembly 104′ with pumpingchamber 402, one-way valves 110′ and 110″ may each be configured to havea low “cracking pressure,” such that the one-way valve is configured totransition from a closed state to an open state with relatively smalldifferential pressures across the one-way valve. For instance, thecracking pressure of each one-way valve can range anywhere from about 25cmH₂O or less to about 5 cmH₂O or less, and as specific examples, thecracking pressure of a given one-way valve could be less than about 25cmH₂O, less than about 15 cmH₂O, less than about 10 cmH₂O, or less thanabout 5 cmH₂O. Further, in at least some implementations, the one-wayvalves 110′ and 110″ may also each be configured to have a low“resealing pressure,” such that the one-way valve is configured totransition from an open state to a closed state with small differentialpressures across the one-way valve. For instance, the resealing pressureof each one-way valve can range anywhere from about 15 cmH₂O or less toabout 2 cmH₂O or less, and as specific examples, the cracking pressureof a given one-way valve could be less than about 15 cmH₂O, less thanabout 10 cmH₂O, less than about 5 cmH₂O, or less than about 2 cmH₂O. Inother implementations of valve assembly 104′ with pumping chamber 402,the cracking and/or resealing pressures of one-way valves 110′ and 110″may be higher.

Pumping chamber 402 is described with reference to examples where theone or more one-way valves take the form of two one-way valves arrangedin series. In some examples where valve assembly 104 includes a singleone-way valve, the valve assembly 104 may further include a compressiblechamber positioned on the inlet or outlet side of the single one-wayvalve, such as positioned between the single one-way valve and a smallnarrowing in the lumen of the flow pathway which may provide hydrostaticresistance. Such a compressible chamber can be used to help initiatefluid flow and/or to enhance or allow a pumping action.

As mentioned above, in the example of FIG. 1A, adjustable outlet lock112 takes the form of a cap, but various adjustable outlet locks 112 arepossible. As one possibility, adjustable outlet lock 112 may take theform of a pinch lever. For instance, with reference to FIGS. 6A-B,adjustable outlet lock 112 may include a lever 600 positioned at outlet108 that may be adjusted to move the lever 600 between (i) a lockedposition 602 (see FIG. 6A) in which lever 600 pinches a tube 604 ofoutlet 108 in order to seal outlet 108 and (ii) an unlocked position 606(see FIG. 6B) in which lever 600 no longer pinches tube 604, thusallowing tube 604 to open and thereby allowing fluid movement throughoutlet 108.

As another possibility, adjustable outlet lock 112 may take the form ofa twist pinch. For instance, with reference to FIGS. 7A-B, adjustableoutlet lock 112 may include a twist pinch 700 positioned at outlet 108that may be adjusted to move twist pinch 700 between (i) a lockedposition 702 (see FIG. 7A) in which twist pinch 700 pinches a tube 704of outlet 108 in order to seal outlet 108 and (ii) an unlocked position706 in which twist pinch 700 no longer pinches tube 704, thus allowingtube 704 to open and thereby allowing fluid movement through outlet 108.

As yet another possibility, adjustable outlet lock 112 may take the formof a twist cap that activates pinch arms. For instance, with referenceto FIGS. 8A-D, adjustable outlet lock 112 may include a twist cap 800positioned at outlet 108 that may be adjusted to move twist cap 800between (i) a locked position 802 (see FIG. 8C and FIG. 8D, which is across-sectional view of adjustable outlet lock 112 taken along line8D-8D in FIG. 8C) in which twist cap 800 forces pinch arms 808 to pincha tube 804 of outlet 108 in order to seal outlet 108 and (ii) anunlocked position 806 (see FIG. 8A and FIG. 8B, which is across-sectional view of adjustable outlet lock 112 taken along line8B-8B in FIG. 8A) in which twist cap 800 allows pinch arms 808 to flexoutward, thus allowing tube 804 to open and thereby allowing fluidmovement through outlet 108. Another example twist cap that activatespinch arms is illustrated in FIGS. 9A-C. As shown, adjustable outletlock 112 may include a threaded twist cap 900 positioned at outlet 108that may be adjusted to move threaded twist cap 900 between (i) a lockedposition 902 (see FIG. 9C) in which threaded twist cap 900 forces pincharms 908 to pinch a tube 904 of outlet 108 in order to seal outlet 108and (ii) an unlocked position 906 (see FIG. 9B) in which threaded twistcap 900 allows pinch arms 908 to flex outward, thus allowing tube 904 toopen and thereby allowing fluid movement through outlet 108. As shown inFIG. 9C, there is a partial conical taper on the inside of twist cap 900that engages the pinch arms 908 when twist cap 900 is screwed all theway on that closes the pinch arms 908. Further, when twist cap ispartially unscrewed (see FIG. 9B), the partial conical taper on theinside of twist cap 900 disengages and releases the pinch arms 108.Additionally, as indicated in FIGS. 9A-B, tube 904 may be opened whenthe inside of twist cap 900 disengages and releases the pinch arms 108(see FIG. 9B), and, with continued unscrewing, twist cap 900 can becompletely disengaged from pinch arms 908 (see FIG. 9A).

As yet another possibility, adjustable outlet lock 112 may take the formof an offset device. For instance, with reference to FIGS. 10A-B,adjustable outlet lock 112 may include an offset device 1000 positionedat outlet 108 that may be adjusted to move offset device 1000 between(i) a locked position 1002 (see FIG. 10A) in which offset device 1000blocks outlet 108 in order to seal outlet 108 and (ii) an unlockedposition 1006 (see FIG. 10B) in which offset device 1000 no longerblocks outlet 108 thereby allowing fluid movement through outlet 108.

FIGS. 11A-B illustrate yet another example adjustable outlet lock, whichin this example is disposed on valve assembly 104′. In this example,adjustable outlet lock 112 takes the form of a removable locking cap1100 positioned at outlet 108 that may be adjusted to move locking cap1100 between (i) a locked position 1102 (see FIG. 11A) in whichremovable locking cap 1100 blocks outlet 108 in order to seal outlet 108and (ii) an unlocked position 1106 in which removable locking cap 1100no longer blocks outlet 108 thereby allowing fluid movement throughoutlet 108.

FIGS. 12A-B illustrate yet another example adjustable outlet lock, whichin this example is disposed on valve assembly 104′. In this example,adjustable outlet lock 112 takes the form of a rotatable locking valve1200 positioned at outlet 108 that may be adjusted to move rotatablelocking valve 1200 between (i) a locked position 1202 (see FIG. 12A) inwhich rotatable locking valve 1200 blocks outlet 108 in order to sealoutlet 108 and (ii) an unlocked position 1206 in which rotatable lockingvalve 1200 no longer blocks outlet 108 thereby allowing fluid movementthrough outlet 108.

Other example adjustable outlet locks are possible as well, including,for instance, ball-valves, and stop-cocks, and external clamps, amongother possibilities. Further, in examples where the adjustable outletlock comprises a removable cap, valve assembly 104 may also include atether for the removable cap, so the removable cap remains attached tovalve assembly 104 when a person is draining fluid from cavity 114 andthe removable cap is in the unlocked position.

As mentioned above, a person may drain the fluid from cavity 114 untilcavity 114 is empty and/or a desired amount of fluid has been drainedfrom the cavity. The amount of fluid drained using fluid-managementsystem 100 may depend on various factors, such as the cavity beingdrained, the amount of fluid in the cavity being drained, an amount oftime available for draining, a recommend amount of fluid to drain, amongother possibilities. In an example, when draining a pleural cavity, aperson may drain approximately 100 to 200 milliliters per day. Inanother example, when drain a peritoneal cavity, a person may drainapproximately 0.75 to 1.25 liters a day. Other examples are possible aswell.

As mentioned above, the disclosed fluid-management system 100 can remainwith the person at all times. When a person is not draining the bodycavity, the person may secure the external portions of thefluid-management system to the person's body. For example, the externalportion of the fluid-management system may be secured to the person(e.g., via an appropriate securing mechanism such as a gauze pad and/ormedical tape, among other possibilities), such as external portion 117of fluid-management system 100 shown in FIG. 13 . In some examples, theperson may coil the external portion of the implanted tube, so that theexternal portion of the fluid-management system may be secured to theperson (e.g., via an appropriate securing mechanism such as a gauze padand/or medical tape, among other possibilities). For instance, FIG. 14depicts an example of such coiling. In particular, when a person is notdraining the body cavity, the person may coil the external portion ofimplanted tube 116, so that the external portion 117 of fluid-managementsystem 100 may be secured to the person. In cases where the externalportion of the implanted tube may be coiled, the geometry of valveassembly 104 and/or pumping chamber 402 can be sized and shaped tofacilitate positioning within the coiled implanted tube 116 and/or tominimize the profile of the secured fluid-management system.

Further, FIGS. 15A-B depict another example of coiling. In particular,FIG. 15A illustrates an example fluid-management system 100, and FIG.15B illustrates an example arrangement of an external portion 117 of thefluid-management system. With reference to FIG. 15A, fluid managementsystem 100 includes tube 116 for carrying fluid from a body cavity of aperson to valve assembly 104 and external tube 142. In this example,tube 116 may be within or substantially within the person's body, whilevalve assembly 104 (including external tube 142) may be external to theperson's body. In this situation, when a person is not draining the bodycavity, the person may coil external tube 142, so that the externalportion 117 of fluid-management system 100 may be secured to the person.In cases where the external tube may be coiled, the geometry of valveassembly 104 and/or pumping chamber 402 can be sized and shaped tofacilitate positioning within coiled external tube 142 and/or tominimize the profile of the secured fluid-management system.

In some examples, valve assembly 104 or valve assembly 104′ may beconnected to an indwelling catheter, such as an indwelling pleuralcatheter. In order to facilitate attachment to an indwelling catheter,valve assembly 104 or valve assembly 104′ may include an attachmentmechanism for attachment to the indwelling catheter. FIGS. 16 and 17illustrate two examples of connecting an example fluid-management systemincluding valve assembly 104′ to an indwelling catheter.

Turning first to FIG. 16 , FIG. 16 illustrates an example process forconnecting valve assembly 104′ to an indwelling catheter 1602.Indwelling catheter 1602 includes a locking cap 1604. Locking cap 1604may be removed, thereby revealing distal end 1606 of indwelling catheter1602. Valve assembly 104′ may include (i) adjustable outlet lock 112 ona distal end of the valve assembly 104′ and (ii) an attachment system1608 on a proximal end of the valve assembly 104′. The attachment system1608 is configured to attach to distal end 1606 of indwelling catheter.Any suitable attachment system for connecting to distal end 1606 ispossible. In an example, a person may engage attachment system 1608 withdistal end 1606 and twist the valve assembly 104′ and/or attachmentsystem 1608 so that attachment system 1608 connects to distal end 1606.After connecting valve assembly 104′ to indwelling catheter 1602, a usermay control adjustable outlet lock 112 (e.g., open and close adjustableoutlet lock 112 as shown in FIG. 16 ) to drain fluid from the bodycavity as desired.

Turning next to FIG. 17 , FIG. 17 illustrates an example process forconnecting valve assembly 104′ to an indwelling catheter 1702. In thisexample, indwelling catheter 1702 may be damaged and leaking (e.g.,through slit 1703 in indwelling catheter 1702). Indwelling catheter 1702may be clamped of proximate to the person in which indwelling catheter1702 is implanted, and indwelling catheter 1702 may then be cut cleanly,thereby removing the damaged section with slit 1703. Valve assembly 104′may include (i) adjustable outlet lock 112 on a distal end of the valveassembly 104′ and (ii) an attachment system 1708 on a proximal end ofthe valve assembly 104′. The attachment system 1708 is configured toattach to distal end 1706 of the tubing of indwelling catheter 1702. Anysuitable attachment system for connecting to distal end 1706 of thetubing is possible. In an example, attachment system 1708 may beconfigured to provide an interference fit with distal end 1706 of thetubing of indwelling catheter 1702. However, other attachment systemsare possible as well. After connecting valve assembly 104′ to indwellingcatheter 1702, a user may control adjustable outlet lock 112 (e.g., openand close adjustable outlet lock 112) to drain fluid from the bodycavity as desired.

Example methods for facilitating draining of fluid from a body cavityand for draining fluid from a body cavity are also provided. Suchmethods could, for example, be carried out by fluid-management systems100 or 100′ as described with reference to FIGS. 1-17 and/or utilizingfluid-management systems 100 or 100′.

FIG. 18 shows a flowchart of an example method 1800 of fluid management.It should be understood that for this and other processes and methodsdisclosed herein, flowcharts show functionality and operation of onepossible implementation of present embodiments. Alternativeimplementations are included within the scope of the example embodimentsof the present disclosure in which functions may be executed out oforder from that shown or discussed, including substantially concurrentor in reverse order, depending on the functionality involved, as wouldbe understood by those reasonably skilled in the art.

At block 1802, method 1800 involves providing a fluid-management systemfor selectively draining fluid from a body cavity. The fluid-managementsystem comprises a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly, where the valve assemblyis configured to be positioned external to the person's body andcomprises (i) an inlet, (ii) an outlet, (iii) one or more one-way valvespositioned between the inlet and outlet that are each configured to openand close based on fluctuations in pressure between a cavity of aperson's body and the one-way valve, and (iv) an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet. Atblock 1804, method 1800 involves implanting a portion of thefluid-management system into the person's body, such that a proximal endof the tube is in fluid communication with the cavity and the valveassembly is positioned external to the person's body. At block 1806,after the fluid-management system is implanted into the person's body,the person may selectively drain fluid from the body cavity using thefluid-management system, as described above.

FIG. 19 shows a flowchart of an example method 1900 of draining fluidfrom a body cavity of a person to a reservoir external to the person'sbody. In particular, method 1900 is a method of operation of afluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly,where the valve assembly is configured to be positioned external to theperson's body and comprises (i) an inlet, (ii) an outlet, (iii) one ormore one-way valves positioned between the inlet and outlet that areeach configured to open and close based on fluctuations in pressurebetween a cavity of a person's body and the one-way valve, and (iv) anadjustable outlet lock configured to selectively prevent fluid movementthrough the outlet. At block 1902, method 1900 involves while theadjustable outlet lock is in a locked position, the adjustable outletlock preventing fluid movement through the outlet. At block 1904, method1900 involves while the adjustable outlet lock is in an unlockedposition, each of the one or more one-way valves opening and closingbased on fluctuations in pressure between the person's body cavity andthe one-way valve, so as to provide a pumping action to move fluid fromthe body cavity through the tube, into the inlet, and out of the outletto an exterior reservoir. The fluctuations may occur based onrespiratory action of a breathing cycle of the person.

FIG. 20 shows a flowchart of an example method 2000 of draining fluidfrom a body cavity of a person to a reservoir external to the person'sbody. In particular, method 2000 is a method of operation of afluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly,wherein the valve assembly is positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) a plurality of one-wayvalves positioned between the inlet and outlet and that are eachconfigured to open and close based on fluctuations in pressure betweenthe person's body cavity and the one-way valve, wherein the plurality ofone-way valves are housed in a pumping chamber, and (iv) an adjustableoutlet lock configured to selectively prevent fluid movement through theoutlet.

At block 2002, method 2000 involves, while the adjustable outlet lock isin a locked position, an external portion of the fluid-management systemattaching to a body of the person. In an example, the fluid-managementsystem attaches to a chest wall of the person. At block 2004, method2000 involves, while the adjustable outlet lock is in an unlockedposition, the pumping chamber compressing and decompressing, so as toprovide a pumping action to prime the fluid-management system and getfluid moving through the fluid-management system. Further, at block2006, method 2000 involves, while the adjustable outlet lock is in theunlocked position, after the fluid-management system is primed, andwhile the pump chamber is positioned below a level of fluid in the bodycavity, the fluid-management system siphoning fluid from the body cavitythrough the fluid-management system. The fluid may be drained to areservoir external to the person's body. In an example, the pump chamber402 is shown positioned below a level of fluid in the body cavity inFIG. 4B. However, in other examples, the tube may be longer and may bepositioned further below the level of fluid in the body cavity.

FIGS. 21A-C depict an example fluid-management system 2100 and FIG. 21Ddepicts the fluid-management system 2100 implanted in a person's body2102. Fluid-management system 2100 includes a valve assembly 2104 havingan inlet 2106, an outlet 2108, a pumping chamber 2110 between inlet 2106and outlet 2108 and configured to be compressed and decompressed to pumpfluid, a first one-way valve 2112 (see FIGS. 21B-C) positioned on afirst side 2114 of pumping chamber 2110 (e.g., the end of pumpingchamber 2110 near inlet 2106), a second one-way valve 2116 (see FIGS.21B-C) positioned on a second side 2118 of pumping chamber 2110 (e.g.,the end of pumping chamber 2110 near outlet 2108), and an adjustableinlet lock 2120 configured to selectively prevent fluid movement throughinlet 2106.

Fluid-management system 2100 also includes a fluid-management tube 2122for carrying fluid from body cavity 2124 (see FIG. 21D) to valveassembly 2104. Tube 2122 is configured to extend from inlet 2106 to bodycavity 2124 and allow movement of fluid from body cavity 2124 to inlet2106 of valve assembly 2104. Tube 2122 is implanted in person's body2102, such that a proximal end 2126 of tube 2122 is positioned withinbody cavity 2124 and a distal end 2128 is positioned external to body2102. Further, valve assembly 2104 is positioned external to theperson's body 2102.

In some examples, tube 2122 may have a cuff along its length that can beplaced within the tissues of person's body 2102 near the exit of tube2122 from person's body 2102. Such a cuff may, for example, beconstructed from fibers made of a material that allows tissue ingrowthinto the fibers of the cuff, forms a barrier to bacterial entry, andhelps secure tube 2122 in place over time. For instance, such a cuff maybe constructed from a material such as polyethylene terephthalate, amongother possibilities. Further, in some examples, tube 2122 may have afeature along its length configured to allow securing of the tube usinga suture material to person's body 2102.

Body cavity 2124 may be a cavity in person's body 2102 that may build upfluid for which there is a desire or need to selectively drain out ofthe body. In the example of FIG. 21A-D, body cavity 2124 is a pleuralcavity of person's body 2102. However, other body cavities are possible,such as a peritoneal cavity, a cerebrospinal cavity, a pericardialcavity, a breast cavity, or a cavity of a cystic lesion, among otherpossibilities.

Each of first one-way valve 2112 and second one-way valve 2116 isconfigured to open and close based on compression and decompression ofpumping chamber 2110. Compression and decompression of pumping chamber2110 is described further with respect to FIGS. 22A-D. In particular,FIG. 22A shows a cross-sectional schematic view of pumping chamber 2110of valve assembly 2104 in a generally or substantially non-compressedstate with both first one-way valve 2112 and second one-way valve 2116closed. For clarity, first one-way valve 2112 is also referred to hereinas an “inlet one-way valve,” and second one-way valve 2116 is referredto as an “outlet one-way valve.” Inlet one-way valve 2112 is positionedon first side 2114 of pumping chamber 2110 proximate to the inlet ofvalve assembly 2104 and outlet one-way valve 2116 is positioned onsecond side 2118 of pumping chamber 2110 proximate to outlet 2108 ofvalve assembly 2104.

FIG. 22B shows a cross-sectional schematic view of valve assembly 2104in a generally or substantially compressed state. In an example, asshown, a first force 2202 may act on a first wall 2204 causing firstwall 2204 to collapse in towards interior space 2206. Correspondingly, asecond force 2208 may additionally or alternatively act on a second wall2210 causing second wall 2210 to collapse in towards interior space2206.

First force 2202 and second force 2208 may be applied to pumping chamber2110 in any suitable fashion. As one possibility, a person usingfluid-management system 2100 may supply the forces by manuallycompressing pumping chamber with their fingers. As another possibility,valve assembly 2104 may include an electromechanical actuator configuredto apply forces 2202 and 2208. For instance, valve assembly 2104 mayinclude a piezoelectric diaphragm connected to the body of pumpingchamber 2110. The piezoelectric diaphragm may be activated andinactivated by a controller, and both the piezoelectric diaphragm andthe controller may be powered, e.g., by a battery. As another example,valve assembly 2104 may include a piston or cam configured to applyforces 2202 and 2208 to pumping chamber 2110. Other example methods andsystems for applying forces 2202 and 2208 are possible as well.

The collapse of the first wall 2204 and/or second wall 2210 serves todecrease the volume of interior space 2206 and to increase the pressurein interior space 2206. This increase in pressure causes inlet one-wayvalve 2112 to remain closed and causes outlet one-way valve 2116 toopen, and fluid located in interior space 2206 to flow from interiorspace 2206 through outlet one-way valve 2116 and out outlet 2108 (seeFIG. 21B-C). For incompressible fluids, the change of volume experiencedby interior space 2206 in response to the collapse of first wall 2204and/or second wall 2210 will be approximately equal to the volume offluid that moves from interior space 2206 through outlet one-way valve2116. As the fluid moves from interior space 2206 through outlet one-wayvalve 2116, the pressure in interior space 2206 will decrease. Once theinterior pressure equals or substantially equals the pressure in outlet2108, flow will stop and outlet one-way valve 2116 will close as shownin FIG. 22C.

In some examples, the cracking pressure and resealing pressure of eachof inlet one-way valve 2112 and outlet one-way valve 2116 may be thesame as or similar to the cracking pressure and resealing pressure ofone-way valve 110, one-way valve 110′, and/or one-way valve 110″ (andthus the cracking pressure and resealing pressure of each of inletone-way valve 2112 and outlet one-way valve 2116 are not described in asgreat of detail). It should be understood, however, that any of thepossibilities and permutations described with respect to the crackingpressure and resealing pressure of one-way valve 110, one-way valve110′, and/or one-way valve 110″ are also possible with respect to thecracking pressure and resealing pressure of each of inlet one-way valve2112 and outlet one-way valve 2116.

As described above, the body of pumping chamber 2110 may besubstantially resiliently flexible and therefore, after being placed ina compressed state as shown in FIGS. 22B and 22C, valve assembly 2104will return to an uncompressed state as shown in FIGS. 22A and 22D whenat least one of the first force 2202 and the second force 2208 areremoved. As the first wall 2204 returns to its uncompressed state as thefirst force 2202 is removed and/or the second wall 2210 returns to itsuncompressed state as the second force 2208 is removed, the volume ofthe interior space 2206 increases and the pressure in the interior space2206 decreases. The pressure inside the interior space 2206 eventuallydrops sufficiently below the pressure on the inlet 2106 near inletone-way valve 2112 and causes inlet one-way valve 2112 to open and fluidlocated in the inlet to flow into the interior space 2206. In this way,valve assembly 2104 operates as a pump that, generally, draws fluid frominlet 2106 and passes it to outlet 2108.

In some examples, pumping chamber 2110 may be made of material thatallows for pumping chamber 2110 to be compressed and then freelyreturned to its original state. Pumping chamber 2110 may be made of anysuitable material. For example, pumping chamber 2110 may be aresiliently flexible tube, cylinder, or other appropriate shape made ofpolyurethane, silicone, polyvinyl chloride, or latex rubber.Alternatively, pumping chamber 2110 may be made of a combination of twoor more materials where at least one of the component materials providesresilience and at least one of the component materials provides fluidcontainment. For example, pumping chamber 2110 may be composed of anelastic nitinol, steel, polyester, or other elastic component to providefor resiliency and a second fluid containment component such aspolyurethane, silicone, polyvinyl chloride, latex rubber, polyethyleneterephthalate, nylon, polytetrafluoroethylene, polyether block amidesuch as PEBAX®, or the like to provide fluid containment within pumpingchamber 2110. In other examples, such as examples where valve assembly2104 includes an electromechanical actuator (e.g., a piezoelectricdiaphragm, piston, or cam configured to apply forces 2202 and 2208 topumping chamber 2110), the material may be flexible but not resilient(or having limited resilience), as an electromechanical actuator mayprovide both active compression and active rarefication.

In some examples, first one-way valve 2112 and second one-way valve 2116each have the capacity to open an amount such that the cross-sectionalarea of the passage through the one-way valve in the open position islarger than the cross-sectional area of the lumen of inlet 2106, suchthat any debris that may be able to enter into inlet 2106 and/or tube2122 can pass through the one-way valve.

In an example, adjustable inlet lock 2120 is positioned upstream (in thedirection of arrow 2150 (see FIG. 21B)) of first one-way valve 2112. Forinstance, with reference to FIG. 21B, the first one-way valve 2112 maybe positioned within pumping chamber 2110 at position 2132, andadjustable inlet lock 2120 is upstream (in the direction of arrow 2150)of the first-one way valve 2112 at position 2134.

In the example of FIGS. 21A-D, adjustable inlet lock 2120 is illustratedas a twist lock configured to pinch tube 2122 and/or inlet 2106. Forinstance, FIGS. 21A-B illustrate adjustable inlet lock 2120 in theclosed positioned (e.g., in which the twist lock pinches tube 2122positioned at inlet 2106), and FIGS. 21C and 23A-B illustrate adjustableinlet lock 2120 after adjustable inlet lock 2120 has been rotated indirection 2302 to be in the open position (e.g., in which the twist lockno longer pinches tube 2122 at inlet 2106). The rotation may cause thetwist lock to move from the closed position to the open position.Further, rotation in the opposite direction 2304 moves adjustable inletlock 2120 from the open position to the closed position. The twist lockof FIGS. 21A-D functions in a manner similar to the twist cap describedwith reference to FIGS. 8A-D (e.g., twist lock configured to activatepinch arms to pinch tube 2122 at inlet 2106) and thus is not describedin as great of detail.

Although in the example of FIGS. 21A-D, adjustable inlet lock 2120 takesthe form of a twist lock, various adjustable inlet locks 2120 arepossible. For instance, adjustable inlet lock 2120 may take the form ofa twist pinch, a pinch level, and an offset device (e.g., forms similarto the forms of the outlet locks illustrated in FIGS. 6A-B, 7A-B, 9A-C,and 10A-B), among other possibilities.

Operation of the fluid-management system 2100 is described withreference to FIGS. 21D and 24A-D. In order to initiate the drainingprocess, a person may first select an external reservoir 2402 (see FIG.24C) in which to drain the fluid from body cavity 2124. In general, theperson may drain the fluid into any appropriate reservoir such as asink, a commode, and/or a container provided by the person, among otherpossibilities. Further, prior to initiating drainage, the valve assemblyarea may be cleaned with soap and water and/or decontaminated withalcohol, betadine, or chlorhexidine, among other possibilities. In someexamples, when the valve assembly is closed (and/or when open as well),there is clearance so that if alcohol or soap and water were poured overthe locking portion and/or the outlet portion of the fluid managementsystem (or if this portion were dunked into such fluid), the alcohol orsoap and water can easily flow between the locking mechanism and outlettubing to provide a more thorough decontamination. Next, to initiate thedraining process, the person may point outlet 2108 upward and switchadjustable inlet lock 2120 to the unlocked position (see FIG. 24A).

With outlet 2108 pointed upward and adjustable inlet lock 2120 in theunlocked position, the person may alternately compress and decompresspumping chamber 2110 until pumping chamber 2110 is full or substantiallyfull of fluid (see FIG. 24B compared to FIG. 24A). When pumping chamber2110 is full or substantially full of fluid, the person may then pointoutlet 2108 downward and move outlet 2108 below the level of insertion(see FIG. 24C) and/or to a position that is sufficiently low so as toallow a siphoning action to be initiated and fluid to begin to flow. Atthis level, siphoning flow begins and fluid may be drained into externalreservoir 2402. The flow rate may be controlled by adjusting the heightof the outlet relative to insertion site and flow may be augmented bymanually compressing the pump chamber. Once drainage has stopped, theperson may once again alternately compress and decompress pumpingchamber 2110 to drain additional fluid from body cavity 2124, ifdesired. In an example, the length of tube 2122 (and, more particularly,the length of the portion of tube 2122 that is external to the body) maybe set to control a vacuum level and/or a maximum vacuum that the siphonproduces and/or may produce. Further, in some examples, the one-wayvalves, tubing diameter, and/or tubing length can be selected so as toensure a desired minimum flow rate, such as 25 milliliters per minute(ml/min) or greater, 50 ml/min or greater, 75 ml/min or greater, 100ml/min, 125 ml/min or greater, 150 ml/min or greater, 175 ml/min orgreater, among other possibilities.

Once desired drainage is complete, the person may move adjustable inletlock 2120 to the locked position (see FIG. 24D), thereby isolating tube2122 and body cavity 2124. Pumping chamber 2110 may then be compressed,thereby emptying pumping chamber 2110 and placing it under vacuum as theresilient pumping chamber 2110 attempts to recoil (see FIG. 24D).Finally, the person may clean or decontaminate outlet 2108 (clean withsoap and water and/or decontaminate with alcohol, betadine, orchlorhexidine, among other possibilities).

Closing adjustable inlet lock 2120 fully isolates pumping chamber 2110from the tube 2122 and body cavity 2124. This isolation may prevententry of additional fluid from tube 2122 and/or body cavity 2124 intopumping chamber 2110. In a situation where there is not an inlet lockbetween the tube 2122 and the inlet of the valve assembly, over time(e.g., between drainage sessions when the user is not actively drainingfluid from the body cavity) fluid from the body cavity will flow intothe pumping chamber via the inlet and the inlet one-way valve. In such asituation where there is not an inlet lock between the tube 2122 and theinlet of the valve assembly, while the one-way valve prevents backflow(and thus fluid from the pump chamber is isolated from moving backtowards the body cavity), fluid from the body cavity may still enter thepump chamber via the inlet one-way valve. On the other hand,beneficially, the adjustable inlet lock 2120 can isolate pumping chamber2110 from body cavity 2124, such that fluid from the body cavity isunable to flow into pumping chamber 2110 when adjustable inlet lock 2120is in the locked position.

This isolation provides redundant protection against backflow of fluidfrom pumping chamber 2110 into tube 2122 and/or body cavity 2124, aswell as protection against ingress of bacteria into tube 2122 and/orbody cavity 2124. In particular, not only does one-way valve 2112provide protection against both (i) backflow of fluid from pumpingchamber 2110 into tube 2122 and/or body cavity 2124 and (ii) ingress ofbacteria into tube 2122 and/or body cavity 2124, but the isolationprovided by adjustable inlet lock 2120 also provides protection againstboth (i) backflow of fluid from pumping chamber 2110 into tube 2122and/or body cavity 2124 and (ii) ingress of bacteria into tube 2122and/or body cavity 2124.

Further, with second one-way valve 2116 and adjustable inlet lock 2120closed, compression of the resilient pumping chamber 2110 will evacuatethe contents of pumping chamber 2110 and place pumping chamber 2110under a vacuum. The evacuation of fluid and/or the vacuum at this stagehave multiple advantages. For instance, as one example, beneficially,lack of fluid in pumping chamber 2110 means that accidental compressionof pumping chamber 2110 between uses (e.g., such as accidentalcompression caused by the person laying on pumping chamber 2110 betweenuses) means that pumping chamber 2110 will not be over pressurized. Insome situations, if the pumping chamber was over pressurized andcompressed with a high force (e.g., inadvertent compression such asbeing laid on or sat on), there may be a risk of damage to one or morecomponents of the valve assembly (e.g., damage to one or more of theone-way valves, the joints between a one-way valve and the pumpingchamber body, and/or the body of the pumping chamber, among otherpossibilities). Ensuring that pumping chamber 2110 will not be overpressurized may help to reduce or limit a potential for risk of damageto one or more components of the valve assembly due to overpressurization of pumping chamber 2110.

As another example, lack of fluid in pumping chamber 2110 helps toprevent clotting within pumping chamber 2110. If biological materialsare sitting static in pumping chamber 2110 and these biologicalmaterials can clot, there may be a risk that the material may clot. Thebiological material may include proteins that act as clotting factors,and leaving such material in pumping chamber 2110 for a threshold periodof time (e.g., 6 hours or more, 12 hours or more, 24 hours or more,and/or 48 hours or more) may lead to larger strand fiber formationand/or larger clot formation. Clotting may act to clog valve assembly2104 and make valve assembly 2104 non-functional. Additionally oralternatively, clotting may increase risk of damage to one or morecomponents of the valve assembly (e.g., damage to one or more of theone-way valves and/or the joints between a one-way valve and the pumpingchamber body, among other possibilities), so preventing or limitingclotting may beneficially prevent or reduce risk of damage to one ormore components of the valve assembly.

As another example, lack of fluid in pumping chamber 2110 also meansthat there is less biological material within fluid-management system2100, such that if bacteria were to ingress into pumping chamber 2110during use of fluid-management system 2100, there is less materialwithin which that bacteria may grow. Bacteria may lead to an infectionand thus it may be desirable to prevent or limit bacteria growth withinthe fluid-management system. Biological material may include proteinsand/or solute that may act as a bacterial medium in which bacteria maygrow. Lack of fluid in pumping chamber 2110 may prevent or limitbacterial medium in the pumping chamber.

Further, the placement of valve assembly 2104 of fluid-management systemoutside of the person's body may also help to prevent or limit bacterialgrowth/activity. In this regard, given the placement of valve assembly2104 outside the person's body, temperature in pumping chamber 2110would also be lower than temperature within the person's body, whichserves to limit or decrease rate of bacterial growth/activity and alsolimit or decrease rate of clot formation.

As yet another example, the maintained vacuum within pumping chamber2110 also provides a biasing pressure gradient to limit or preventbacterial ingress from pumping chamber 2110 into tube 2122 andsubsequently into body cavity 2124. In this regard, while first one-wayvalve 2112 and adjustable inlet lock 2120 both provide an impediment tofluid moving from pumping chamber 2110 into tube 2122, in somesituations, the valve assembly may have micropores or micro passagewaysbetween pumping chamber 2110 and tube 2122, and it may be possible for asmall amount of fluid to move upstream from pumping chamber 2110 to tube2122 via micropores or micro passageways into tube 2122. Therefore, in ascenario where bacteria were to get into valve assembly 2104, it may bepossible for bacteria to move upstream from pumping chamber 2110 to tube2122 via micropores or micro passageways into tube 2122.

However, a biasing pressure gradient provided by a maintained vacuumwithin pumping chamber may make it more difficult for fluid to moveupstream from pumping chamber 2110 to tube 2122 via micropores or micropassageways into tube 2122 (compared to a situation in which there is nomaintained vacuum in the pumping chamber). Since the pressure gradientmay make it difficult for fluid to move upstream, the fluid will remainin pumping chamber 2110 and be unable to move moving upstream frompumping chamber 2110 to tube 2122 via micropores or micro-passageways inthe valve assembly.

As an illustrative example, in a situation where the pumping chamber isat a −10 cmH₂O pressure and tube 2122 is at atmospheric pressure, fluidmay have more difficulty moving upstream from pumping chamber 2110 totube 2122 via micropores or micro-passageways in valve assembly 2104compared to a situation where a pumping chamber is at atmosphericpressure and a tube is at atmospheric pressure. Therefore, the biasingpressure gradient provided by a maintained vacuum provides an additionalimpediment to bacterial ingress from pumping chamber 2110 into tube2122. In particular, not only do one-way valve 2112 and adjustable inletlock 2120 provide an impediment to bacterial ingress from pumpingchamber 2110 into tube 2122, but the biasing pressure gradient providedby the maintained vacuum within pumping chamber 2110 provides anadditional impediment to bacterial ingress from pumping chamber 2110into tube 2122.

In some examples, valve assembly 2104 is non-removably attached to tube2122. Further, in some examples, adjustable inlet lock 2120 of valveassembly 2104 is non-removably attached to valve assembly 2104.

As mentioned above, each of first one-way valve 2112 and second one-wayvalve 2116 is configured to open and close based on compression anddecompression of pumping chamber 2110. In some examples, each of firstone-way valve 2112 and second one-way valve 2116 is further configuredto open and close based on fluctuations in pressure between the person'sbody cavity 2124 and the one-way valve that occur based on respiratoryaction of a breathing cycle of the person. For instance, in someexamples, first one-way valve 2112 and second one-way valve 2116 areconfigured in the manner described above with respect to one-way valves110, 110′ and 110″. It should be understood that any of thepossibilities and permutations described with respect to one-way valves110, 110′ and 110″ are also possible with respect to first one-way valve2112 and second one-way valve 2116.

In addition to or alternative to including an adjustable inlet lock suchas adjustable inlet lock 2120, the fluid management system may includean adjustable outlet lock. For instance, FIGS. 25A-C depict an examplefluid-management system 2500 and FIG. 25D depicts the fluid-managementsystem 2500 implanted in a person's body 2502. Fluid-management system2500 includes a valve assembly 2504 having an inlet 2506, an outlet2508, a pumping chamber 2510 between the inlet and outlet and configuredto be compressed and decompressed to pump fluid, a first one-way valve2512 (see FIGS. 25B-C) positioned on a first side 2514 of pumpingchamber 2510 (e.g., the end of pumping chamber near inlet 2506), asecond one-way valve 2516 (see FIGS. 25B-C) positioned on a second side2518 of pumping chamber 2510 (e.g., the end of pumping chamber 2510 nearoutlet 2508), an adjustable inlet lock 2520 configured to selectivelyprevent fluid movement through inlet 2506, and an adjustable outlet lock2530 configured to selectively prevent fluid movement through outlet2508.

Fluid-management system 2500 also includes a fluid-management tube 2522for carrying fluid from body cavity 2524 to valve assembly 2504. Tube2522 is configured to extend from inlet 2506 to body cavity 2524 andallow movement of fluid from cavity 2524 to inlet 2506 of valve assembly2504. Tube 2522 is implanted in person's body 2502, such that a proximalend 2526 of tube 2522 is positioned within cavity 2524 and a distal end2528 is positioned external to body 2502. Further, valve assembly 2504is positioned external to the person's body 2502.

In some examples, tube 2522 may have a cuff along its length that can beplaced within the tissues of person's body 2502 near the exit of tube2522 from person's body 2502. Such a cuff may, for example, beconstructed from fibers made of a material that allows tissue ingrowthinto the fibers of the cuff, forms a barrier to bacterial entry, andhelps secure tube 2522 in place over time. For instance, such a cuff maybe constructed from a material such as polyethylene terephthalate, amongother possibilities. Further, in some examples, tube 2522 may have afeature along its length configured to allow securing of the tube usinga suture material to person's body 2502.

Cavity 2524 may be a cavity in person's body 2502 that may build upfluid for which there is a desire or need to selectively drain out ofthe body. In the example of FIG. 25A-D, cavity 2524 is a pleural cavityof person's body 2502. However, other body cavities are possible, suchas a peritoneal cavity, a cerebrospinal cavity, a pericardial cavity, abreast cavity, or a cavity of a cystic lesion, among otherpossibilities.

Each of first one-way valve 2512 and second one-way valve 2516 isconfigured to open and close based on compression and decompression ofpumping chamber 2510. Compression and decompression of pumping chamber2510 is similar to the compression and decompression of pumping chamber2110 as described with respect to FIGS. 22A-D, and thus is not describedin as great of detail. It should be understood, however, that any of thepossibilities and permutations described with respect to the compressionand decompression of pumping chamber 2110 are also possible with respectto the compression and decompression of pumping chamber 2510. Similarly.the cracking pressure and resealing pressure of each of first one-wayvalve 2512 and second one-way valve 2516 may be the same as or similarto the cracking pressure and resealing pressure of the cracking pressureand resealing pressure of inlet one-way valve 2112 and outlet one-wayvalve 2116, and thus is not described in as great of detail. It shouldbe understood, however, that any of the possibilities and permutationsdescribed with respect to the cracking pressure and resealing pressureof inlet one-way valve 2112 and outlet one-way valve 2116 are alsopossible with respect to the cracking pressure and resealing pressure ofeach of first one-way valve 2512 and second one-way valve 2516.

In an example, adjustable inlet lock 2520 is positioned upstream (in thedirection of arrow 2550) of first one-way valve 2512 and adjustableoutlet lock 2530 is positioned downstream (in the direction of arrow2552) of second one-way valve 2516. For instance, with reference to FIG.25B, first one-way valve 2512 may be positioned within pumping chamber2510 at position 2532, and adjustable inlet lock 2520 is upstream of thefirst-one way valve 2512 at position 2534. Further, second one-way valve2516 may be positioned within pumping chamber 2510 at position 2536, andadjustable outlet lock 2530 is downstream of the second one-way valve2516 at position 2538.

In some examples, valve assembly 2504 is non-removably attached to tube2522. Further, in some examples, adjustable inlet lock 2520 of valveassembly 2504 is non-removably attached to valve assembly 2504, andadjustable outlet lock 2530 is non-removably attached to valve assembly2504.

Operation of the fluid-management system 2500 is described withreference to FIGS. 26A-E. In order to initiate the draining process, aperson may first select an external reservoir 2600 (see FIG. 26C) inwhich to drain the fluid from cavity 2524. In general, the person maydrain the fluid into any appropriate reservoir such as a sink, acommode, and/or a container provided by the person, among otherpossibilities. Further, prior to initiating drainage, the valve assemblyarea may be cleaned with soap and water and/or decontaminated withalcohol, betadine, or chlorhexidine, among other possibilities. In someexamples, when the valve assembly is closed (and/or when open as well),there is clearance so that if alcohol or soap and water were poured overthe locking portion and/or the outlet portion of the fluid managementsystem (or if this portion were dunked into such fluid), the alcohol orsoap and water can easily flow between the locking mechanism(s) andoutlet tubing to provide a more thorough decontamination. Next, toinitiate the draining process, the person may point the outlet 2508upward, switch adjustable inlet lock 2520 to the unlocked position, andswitch adjustable outlet lock 2530 to the unlocked position (see FIG.26A).

With outlet 2508 pointed upward, adjustable inlet lock 2520 in theunlocked position, and adjustable outlet lock 2530 in the unlockedposition, the person may alternately compress and decompress pumpingchamber 2510 until pumping chamber 2510 is full or substantially full offluid (see FIG. 26B compared to FIG. 26A). When pumping chamber 2510 isfull or substantially full of fluid, the person may then point outlet2508 downward and move outlet 2508 below the level of insertion (seeFIG. 26C) and/or to a position that is sufficiently low so as to allow asiphoning action to be initiated and fluid to begin to flow. At thislevel, siphoning flow begins and fluid may be drained into reservoir2600 (see FIG. 26C). The flow rate may be controlled by adjusting theheight of the outlet relative to insertion site and flow may beaugmented by manually compressing the pump chamber. Once drainage hasstopped, the person may once again alternately compress and decompresspumping chamber 2510 to drain additional fluid from body cavity 2524, ifdesired. In an example, the length of tube 2522 (and, more particularly,the length of the portion of tube 2522 that is external to the body) maybe set to control a vacuum level and/or a maximum vacuum that the siphonproduces and/or may produce.

Further, in some examples, the one-way valves, tubing diameter, and/ortubing length can be selected so as to ensure a desired minimum flowrate, such as 25 milliliters per minute (ml/min) or greater, 50 ml/minor greater, 75 ml/min or greater, 100 ml/min, 125 ml/min or greater, 150ml/min or greater, 175 ml/min or greater, among other possibilities.

As a particular illustrative experimental example, for a valve assemblyhaving a first set of one-way valves and a tube with a 15 mm outerdiameter and a 52 mm length, five experimental runs to measure peakpressure and flow rate during syphoning with a given column height (30cm) were conducted. The peak pressure corresponds to the maximum vacuumthat is generated when the pump chamber is maximally compressed and thenreleased. Further, the column height (which was 30 cm in thisexperiment) is the difference between the fluid level in the chamber andthe outlet. A first experimental run resulted in a peak pressure (cmH₂O) of −98.8 cm H₂O and a flow rate (ml/min) of 66 ml/min. Further, asecond experimental run resulted in a peak pressure of −106.5 and a flowrate of 67 ml/min. Still further, a third experimental run resulted in apeak pressure of −102.7 cm H₂O and a flow rate of 65 ml/min. Yet stillfurther, a fourth experimental run resulted in a peak pressure of −114.1cm H₂O and a flow rate of 68 ml/min. And yet still further, a fifthexperimental run resulted in a peak pressure of −98.7 cm H₂O and a flowrate of 67 ml/min. For this particular illustrative experimentalexample, the experimental results had a mean of a peak pressure of−104.2 cm H₂O (with a standard deviation of +/−6.4) and a mean flow rate(ml/min) of 66.6 ml/min (with a standard deviation of +/−1.1).

As an additional particular illustrative experimental example, for avalve assembly having a second set of one-way valves (different from theaforementioned first set) and a tube with a 15 mm outer diameter and a55 mm length, five experimental runs to measure peak pressure and flowrate during syphoning with a given column height (30 cm) were conducted.A first experimental run resulted in a peak pressure of −132.6 cm H₂Oand a flow rate (ml/min) of 157.5 ml/min. Further, a second experimentalrun resulted in a peak pressure of −129.6 and a flow rate of 156.3ml/min. Still further, a third experimental run resulted in a peakpressure of −133.2 cm H₂O and a flow rate of 155.0 ml/min. Yet stillfurther, a fourth experimental run resulted in a peak pressure of −141.5cm H₂O and a flow rate of 155.0 ml/min. And yet still further, a fifthexperimental run resulted in a peak pressure of −140.8 cm H₂O and a flowrate of 157.5 ml/min. For this additional particular illustrativeexperimental example, the experimental results had a mean of a peakpressure of −133.5 cm H₂O (with a standard deviation of +/−5.3) and amean flow rate (ml/min) of 156.3 ml/min (with a standard deviation of+/−1.25).

Other example peak pressures and flow rate are possible as well.

Once desired drainage is complete, the person may move adjustable inletlock 2520 to the locked position, thereby isolating tube 2522 and bodycavity 2524 (see FIG. 26D). Pumping chamber 2510 may then be compressed,thereby emptying the pumping chamber 2510 and placing it under vacuum asthe resilient pumping chamber 2510 attempts to recoil and outlet one-wayvalve 2516 closes. Finally, the person may clean or decontaminate outlet2508 (clean with soap and water and/or decontaminate with alcohol,betadine, or chlorhexidine, among other possibilities).

Once outlet 2508 has been cleaned or decontaminated, the person may moveadjustable outlet lock 2530 to the locked position (see FIG. 26E). Inthis configuration, not only is pumping chamber 2510 protected againstbackflow from the exterior by outlet one-way valve 2516, but also by thebidirectional blockade provided the locked adjustable outlet lock 2530.Similarly, not only is tube 2522 in fluid communication with body cavity2524 protected against backflow by first one-way valve 2512, but tube2522 is also protected against backflow the bidirectional blockadeprovided by the locked adjustable inlet lock 2520. Additionally, theclosed adjustable inlet lock 2520 and the closed adjustable outlet lock2530 isolate the interior of pumping chamber 2510 from the exterior andbody cavity 2524, provide bidirectional barriers between the exteriorand body cavity 2524, and lastly provide redundant backflow prevention.

In the example of FIGS. 25A-D, adjustable inlet lock 2520 is illustratedas a twist lock configured to pinch tube 2522 and/or inlet 2506. Forinstance, FIGS. 25A-B illustrate adjustable inlet lock 2520 in theclosed positioned (e.g., in which the twist lock pinches tube 2522positioned at inlet 2506), and FIGS. 21C and 26A-C illustrate adjustableinlet lock 2520 after it has been rotated in direction 2602 to be in theopen position (e.g., in which the twist cap no longer pinches tube 2522at inlet 2506). The rotation may cause the twist lock to move from theclosed position to the open position. Further, rotation in the oppositedirection 2604 moves adjustable inlet lock 2520 from the open positionto the closed position. The twist lock/adjustable inlet lock 2520 ofFIGS. 25A-D functions in a manner similar to the twist cap describedwith reference to FIGS. 8A-D (e.g., twist lock configured to activatepinch arms to pinch tube 2522 at inlet 2506) and thus is not describedin as great of detail.

Although in the example of FIGS. 25A-D, adjustable inlet lock 2520 takesthe form of a twist lock, various adjustable inlet locks 2520 arepossible. For instance, adjustable inlet lock 2520 may take the form ofa twist pinch, a pinch level, and an offset device (e.g., forms similarto the forms of the outlet locks illustrated in FIGS. 6A-B, 7A-B, 9A-C,and 10A-B), among other possibilities.

Similarly, in the example of FIGS. 25A-D, adjustable outlet lock 2530 isillustrated as a twist lock configured to pinch outlet 2508 and/or atube in fluid communication with outlet 2508. For instance, FIGS. 25A-Billustrate adjustable outlet lock 2530 in the closed positioned (e.g.,in which the twist lock pinches a tube in fluid communication withoutlet 2508, and FIGS. 25C and 26A-D illustrate adjustable outlet lock2530 after it has been rotated in direction 2602 to be in the openposition (e.g., in which the twist lock no longer pinches the tube influid communication with outlet 2508). The rotation may cause the twistlock to move from the closed position to the open position. Further,rotation in the opposite direction 2604 moves the twist lock from theopen position to the closed position. The twist lock/adjustable outletlock 2530 of FIGS. 25A-D functions in a manner similar to the twist capdescribed with reference to FIGS. 8A-D (e.g., twist lock configured toactivate pinch arms to pinch outlet 2508 and/or a tube in fluidcommunication with outlet 2508) and thus is not described in as great ofdetail.

Although in the example of FIGS. 25A-D, adjustable outlet lock 2530takes the form of a twist lock, various adjustable outlet locks 2530 arepossible. For instance, adjustable outlet lock 2530 may take the form ofa twist pinch, a pinch level, and an offset device (e.g., forms similarto the forms of the outlet locks illustrated in FIGS. 6A-B, 7A-B, 9A-C,and 10A-B), among other possibilities.

In some examples, adjustable inlet lock 2520 and adjustable outlet lock2530 are configured such that each may be grabbed by a user and twistedat the same time, so that both adjustable locks may be opened in asingle phase. For instance, adjustable inlet lock 2520 and adjustableoutlet lock 2530 may have the same right-hand thread or same left-handthread such that both may be twisted open at the same time in a singlephase, rather than requiring a user to open the locks sequentially intwo different phases. Such a single-phase opening process may be useful,for instance, for users that suffer from dexterity issues.

As mentioned above, each of first one-way valve 2512 and second one-wayvalve 2516 is configured to open and close based on compression anddecompression of pumping chamber 2510. In some examples, each of firstone-way valve 2512 and second one-way valve 2516 is further configuredto open and close based on fluctuations in pressure between the person'sbody cavity 2524 and the one-way valve that occur based on respiratoryaction of a breathing cycle of the person. For instance, in someexamples, first one-way valve 2512 and second one-way valve 2516 areconfigured in the manner described above with respect to one-way valves110, 110′ and 110″. It should be understood that any of thepossibilities and permutations described with respect to one-way valves110, 110′ and 110″ are also possible with respect to first one-way valve2512 and second one-way valve 2516.

In some examples, the pumping chamber 2110 of fluid-management system2100, the pumping chamber 2510 of fluid-management system 2500, and/orthe pumping chamber 402 of fluid-management system 100′ are eachconfigured to provide the ability to recoil at a given pressure. In thisregard, the thickness of the body of the pumping chamber may affect therecoil pressure provided by the pumping chamber. For instance, as anillustrative example, a pumping chamber formed of silicon and having ahalf inch internal diameter and a ⅝-inch external diameter may provide arecoil pressure of approximately −100 cmH₂O. However, in anotherexample, a pumping chamber formed of silicon and having thicker wallsmay provide a greater recoil pressure. For instance, in an example, apumping chamber formed of silicon and having a half inch internaldiameter and a ⅞-inch external diameter will provide a greater recoilpressure than the recoil pressure provided by the pumping chamber formedof silicon and having a half inch diameter and a ⅝-inch externaldiameter. Further, the shape of the pumping chamber may also affect therecoil pressure provided by the pumping chamber. For instance, in anexample, a pumping chamber with first shape (e.g., oval) and a givenwall thickness will recoil with a different pressure than a pumpingchamber with a second, different shape (e.g., tubular) and the samegiven wall thickness. Other examples are possible as well.

In an example, the pumping chamber of the disclosed fluid-managementsystem is configured to have a given maximum recoil pressure. Variousmaximum recoil pressures are possible. For instance, in an example, themaximum recoil pressure can range anywhere from about −300 cmH₂O toabout −50 cm cmH₂O, and as specific examples, the maximum recoilpressure could be about −300 cmH₂O, −275 cmH₂O, −250 cmH₂O, −225 cmH₂O,−200 cmH₂O, about −175 cmH₂O, about −150 cmH₂O, about −125 cmH₂O, about−100 cmH₂O, about −75 cmH₂O, or about −50 cmH₂O, among otherpossibilities.

Within examples, the maximum recoil pressure for a pumping chamber maybe tuned based on the shape and/or thickness of the pumping chamber.More particularly, the shape and/or thickness of the pumping chamber maybe selected based on a desired maximum recoil pressure for the pumpingchamber.

In an example, the valve assembly may include a compression limiterconfigured to limit the amount of compression that is possible. In sucha case, if the pumping chamber is compressed completely to thecompression limiter, then it can recoil fully and generate a maximumsuction. For instance, the pumping chamber may comprise sections oflocalized thickening of the pumping chamber wall that are positionedopposite one another, such that when the pumping chamber is compressed,these thickened areas come together to meet, prevent furthercompression, and limit the amount of pump chamber volume change thatoccurs with compression. In another example, the compression limiterinclude one or more ridges and/or one or more protrusions attached tothe pumping chamber wall(s) that limit compression. Other compressionlimiters are possible as well.

Providing a given maximum recoil pressure may be beneficial for avariety of reasons. As one example, having given maximum recoil pressuremay be desirable so as to maintain comfort for users that use thefluid-management system. In practice, a recoil pressure that is too highmay be uncomfortable for users, so a given maximum recoil pressure maybe selected so as to maintain and/or ensure a comfortable operation forthe user. As another example, having given maximum recoil pressure maybe desirable so as to provide the ability to provide a large enoughrecoil pressure that is effective to re-expand a user's lung in theevent that a user has a trapped lung. Trapped lung syndrome refers to acondition in which the lung does not fully expand during pleuraldrainage to oppose the chest wall. Typically, for lungs in which thereis fluid in the chest and the fluid is drained, a normal, healthy lungwill expand and fill that space. Further, even the majority ofdistressed lungs will expand and fill that space back up after draining.However, some lungs may have a thickened surface and/or have beencollapsed and/or altered long enough that, when the fluid is drainedfrom that space, the lung does not expand fill that space back up afterdraining. Therefore, the maximum recoil pressure may be selected so asto provide a large enough recoil pressure that is effective to helpre-expand a user's lung in the event that a user has a trapped lung(e.g., a selected maximum recoil pressure between −1000 and −200 cmH₂O,among other possibilities). As yet another example, having given maximumrecoil pressure may help to overcome catheter occlusion. A given maximumrecoil pressure may be beneficial for other reasons as well.

Further, in some examples, the pumping chamber 2110 of fluid-managementsystem 2100, the pumping chamber 2510 of fluid-management system 2500,and/or the pumping chamber 402 of fluid-management system 100′ are eachconfigured to provide the ability to recoil at a plurality of differentpressures. For instance, the body of the pumping chamber may be shapedand/or sized to recoil at a plurality of different pressures. In thisregard, as an illustrative example, FIG. 27 illustrates a pumpingchamber 2700 configured to provide the ability to recoil at twodifferent pressures. In particular, pumping chamber 2700 includes afirst portion 2702 configured to be compressed and to recoil with afirst pressure (illustrated as −200 cmH₂O in this example) and a secondportion 2704 configured to be compressed and to recoil with a secondpressure (illustrated as −100 cmH₂O in this example). In order toprovide the ability to recoil at different pressures, the thickness offirst portion 2702 may be different than the thickness of second portion2704.

As another illustrative example, FIG. 28 a illustrates a pumping chamber2800 configured to provide the ability to recoil at two differentpressures. In particular, pumping chamber 2800 includes a first portion2802 configured to be compressed and to recoil with a first pressure(illustrated as −20 cmH₂O in this example) and a second portion 2804configured to be compressed and to recoil with a second pressure(illustrated as −30 cmH₂O in this example). In this example, the firstportion 2802 is a first set of walls of pumping chamber 2800 (e.g., thewalls positioned at 0 degrees and 180 degrees relative to an axis of thepumping chamber), whereas second portion 2804 is a second set of wallsof pumping chamber 2800 (e.g., the walls positioned at 90 degrees and270 degrees relative to the axis of the pumping chamber). A user may,for example, use their fingers to compress pumping chamber 2800 at theset of walls that correspond to the desired recoil pressure for theuser. In order to provide the ability to recoil at different pressures,the thickness of first portion 2802 may be different than the thicknessof second portion 2804. For instance, with reference to FIG. 28B (whichis a cross-section of the body of the pumping chamber taken along lineA-A of FIG. 28A), the body of pumping chamber 2800 is configured suchthat the thickness of second portion 2804 is greater than the thicknessof first portion 2802. Other examples are possible as well.

Within examples, the plurality of different recoil pressures for apumping chamber may be tuned based on the shape and/or thickness of thepumping chamber. More particularly, the shape and/or thickness of thepumping chamber may be selected based on the desired plurality ofdifferent recoil pressures for the pumping chamber.

Additionally or alternatively, within examples, the plurality ofdifferent recoil pressures for a pumping chamber may be provided by aplurality of compression limiters. For instance, the valve assembly mayinclude (i) a first compression limiter for a first portion of thepumping chamber such that the valve assembly is configured to, aftercompression of the first portion, generate a first suction pressure and(ii) a second compression limiter for a second portion of the pumpingchamber such that the valve assembly is configured to, after compressionof the second portion, generate a second suction pressure. In such acase, (i) if the pumping chamber is compressed at a first portion of thepumping chamber to the first compression limiter, then it can recoil andgenerate a first suction, and (ii) if the pumping chamber is compressedat the second portion to the second compression limiter, then it canrecoil and generate a second, different suction.

As an illustrative example, FIG. 45 a illustrates a pumping chamber 4500configured to provide the ability to recoil at two different pressures.In particular, pumping chamber 4500 includes a first portion 4502configured to be compressed and to recoil with a first pressure(illustrated as −50 cmH₂O in this example) and a second portion 4504configured to be compressed and to recoil with a second pressure(illustrated as −100 cmH₂O in this example). In this example, withreference to FIG. 45 b , the pumping chamber 4500 includes a firstcompression limiter 4506 for the first portion 4502 and a secondcompression limiter 4508 for the second portion 4504. First compressionlimiter 4506 comprises thickened wall sections of a first thickness, andsecond compression limiter 4508 includes thickened wall sections of asecond thickness. With reference to FIG. 45 c , when first portion 4502is compressed, the thickened wall sections of compression limiter 4506come together to meet and prevent further compression. When portion 4502is released, pumping chamber wall portions 4510 a-d provide recoilforce. On the other hand, if second portion 4504 were compressed ratherthan first portion 4502, the compression limiter 4508 would allow formore deformation than compression limiter 4506. Therefore, if secondportion 4506 is compressed, the recoil sections would be more deformedand recoil more, thereby providing a higher recoil pressure.

Providing a plurality of different recoil pressures may be beneficialfor a variety of reasons. As one example, it may be desirable to have aplurality of different recoil pressures to account for user preference(e.g., user preferences related to preferred pump speed and/or differentcomfort levels or pain-tolerance levels of the user of thefluid-management system). For instance, providing a plurality ofdifferent recoil pressures from which the user can select a given recoilpressure during operation of the fluid-management system may allow theuser to select a recoil pressure based on desired pump speed for theuser and/or comfort level or pain-tolerance level of the user.

As another example, plurality of recoil pressures may be useful for asituation in which a user may have a trapped lung. For instance, in anexample, the pumping chamber may provide three levels of vacuum, whichin this example may be a low vacuum (e.g., a recoil pressure in a rangeof −20 to −50 cm cmH₂O), medium vacuum (e.g., a recoil pressure in arange of −75 to −200 cm cmH₂O), and a high vacuum (e.g., a recoilpressure in a range of −200 to −250 cm cmH₂O). As mentioned above, ahigher vacuum pressure may cause more discomfort to a user compared to alower vacuum pressure. Therefore, a user may initially select the lowvacuum for comfort level or pain-tolerance level of the user. However,if the low vacuum is insufficient to cause or help the trapped lung tore-expand, a user may pump the pumping chamber to generate the mediumvacuum, so as to attempt to re-expand the trapped lung. Further, if themedium vacuum is insufficient to cause or help the trapped lung tore-expand, a user may pump the pumping chamber to generate the highvacuum, so as to attempt to re-expand the trapped lung. A plurality ofrecoil pressures may be beneficial for other reasons as well.

In some examples, the pumping chamber 2110 of fluid-management system2100, the pumping chamber 2510 of fluid-management system 2500, and/orthe pumping chamber 402 of fluid-management system 100′ are eachconfigured to provide the ability to cut or break-up fibrous strandsduring compression of the pumping chamber. In this regard, FIGS. 29A-Billustrate a pumping chamber 2900 that includes a plurality of firstprotrusions 2902 and a plurality of second protrusions 2904. FIG. 29Billustrates a partial cross-sectional view of pumping chamber 2900 takenalong line B-B. The first protrusions 2902 are disposed on a firstportion 2906 (e.g., a first inner wall) of a body 2910 of the pumpingchamber 2900 that is opposite a second portion 2908 (e.g., a secondinner wall) of body 2910 on which the second protrusions 2904 aredisposed. The plurality of first protrusions 2902 is configured tointerweave with the plurality of second protrusions during compressionof the pumping chamber. By interweaving with one another duringcompression, the pluralities of protrusions may cut or break-up fibrousstrands during compression of the pumping chamber 2900, potentiallyallowing them to pass more readily through the fluid-management system(and, more particularly, through pumping chamber 2900 and out outlet2912).

In some examples, fluid-management system 2100, fluid-management system2500, and/or fluid-management system 100′ are each configured to provideaccess to the pumping chamber, the inlet of the valve assembly, and/orthe tube of the fluid-management system. Further, in some examples,fluid-management system 100 may be configured to provide access to theinlet of the valve assembly and/or the tube of the fluid-managementsystem.

Access to the pumping chamber, the inlet of the valve assembly, and/orthe tube of the fluid-management system may be beneficial for a varietyof reasons. For instance, with respect to the pumping chamber, access tothe pumping chamber may be desirable to access the pumping chamberand/or the one-way valves within the pumping chamber. In an example,access to the pumping chamber may be useful for flushing out a clot. Asanother example, access to the pumping chamber may be useful forobtaining a sample of the material (e.g., obtaining a sample of materialif material within the pumping chamber were to clot). Further, withrespect to the inlet of the valve assembly and/or the tube of thefluid-management system, access to the inlet of the valve assemblyand/or the tube of the fluid-management system may be desirable todeliver therapy through the tube. For instance, access to the inletand/or tube may be useful for delivering a drug (e.g., a medicine, anantibiotic, a chemotherapy agent, among other possibilities) to the bodycavity that is in fluid communication with the tube (e.g., the pleuralcavity). As another example, access to the inlet and/or tube may beuseful in the event of a clot in one or more of the one way valves(e.g., to inject fluid to flush out the clot). As another example,access to the tube may be useful for obtaining a sample of the material(e.g., obtaining a sample of material if material within the inletand/or tube were to clot).

To facilitate access to access to the pumping chamber, the inlet of thevalve assembly, and/or the tube of the fluid-management system,fluid-management system 2100, fluid-management system 2500, and/orfluid-management system 100′ may each be configured to provide access tothe pumping chamber, the inlet of the valve assembly, and/or the tube ofthe fluid-management system. For instance, valve assembly 2104, valveassembly 2504, and/or valve assembly 104′ may include one or more of apumping chamber access port and an inlet access port. Further,fluid-management system 100 may be configured to provide access to theinlet of the valve assembly and/or the tube of the fluid-managementsystem. For instance, valve assembly 104 may include an inlet accessport.

In this regard, as an illustrative example of a pumping chamber accessport and an inlet access port, FIG. 30 illustrates a valve assembly 3000that includes a pumping chamber access port 3002 for pumping chamber3004 and an inlet access port 3006. In some examples, pumping chamberaccess port 3002 may be configured to provide access to a needle. Inother examples, pumping chamber access port 3002 may take the form of aneedless access hub or port. Various needless access hubs are possible.As one possibility, the needless access hub may be a needless accessport valve that includes a grommet or plug that may be pushed out of theway, so as provide access to the pumping chamber. Other needless accesshubs are possible as well.

Similarly, in some examples, inlet access port 3006 may be configured toprovide access to a needle. In other examples, inlet access port 3006may take the form of a needless access hub or port. Various needlessaccess hubs are possible. As one possibility, the needless access hubmay be a needless access port valve that includes a grommet or plug thatmay be pushed out of the way, so as provide access to the tube. Otherneedless access hubs are possible as well.

In an example, pumping chamber access port 3002 includes a thickenedarea in a wall of the pumping chamber. The thickened area may beconfigured to be penetrable by a needle so as to allow access by theneedle and to reseal when the needle is removed from the thickenedmaterial. In such an example, the pumping chamber access port 3002 mayfurther include a puncture-resistant material in an area in the walllocated across from the pumping chamber access port. For instance, withreference to FIG. 31A, pumping chamber access port 3002 includes athickened area 3102 in a wall 3104 of the pumping chamber 3004, andpumping chamber 3004 further includes a puncture-resistant material 3106in an area 3108 in wall 3110 located across from pumping chamber accessport 3002. Various puncture-resistant materials are possible. Forinstance, in some examples, the puncture-resistant material may be ahard plastic(s) such as nylon, Teflon, polyethylene terephthalate (PET),and/or polyamide, among other possibilities. In some examples, thepuncture-resistant material may be a metal such as nitinol or stainlesssteel, among other possibilities. Other puncture-resistant materials arepossible as well.

In an example, the area in the wall located across from the pumpingchamber access port is beneath the pumping chamber access port 3002. Thepuncture-resistant material may prevent or limit potential damage to thebody of the pumping chamber 3004 by a needle or other device that may beinserted into pumping chamber access port 3002. Further, in an example,pumping chamber access port 3002 is positioned a threshold distance awayfrom the inlet one-way valve within pumping chamber 3004 (e.g., 2 mm ormore), as well as a threshold distance (e.g., 2 mm or more) away fromthe outlet one-way valve within pumping chamber 3004. In some examples,the threshold distance away from the inlet one-way valve within pumpingchamber 3004 is 2 mm or more, 5 mm or more, or 7 mm or more, among otherpossibilities. In some examples, the threshold distance away from theoutlet one-way valve within pumping chamber 3004 is 2 mm or more, 5 mmor more, or 7 mm or more, among other possibilities. Positioning pumpingchamber access port 3002 in this way may help may prevent or limitpotential damage to the one-way valves by a needle or other device thatmay be inserted into pumping chamber access port 3002.

Turning next to inlet access port 3006, in an example, the inlet accessport includes a thickened area in a wall of the valve assembly. Thethickened area may be configured to be penetrable by a needle so as toallow access by the needle and to reseal when the needle is removed fromthe thickened material. Further, in such an example, the valve assemblymay further include a puncture-resistant material in an area in the walllocated across from the inlet access port. For instance, with referenceto FIG. 31B, inlet access port 3006 includes a thickened area 3112 in awall 3114 of valve assembly 3000, and valve assembly 3000 furtherincludes a puncture-resistant material 3116 in an area 3118 in the wall3120 located across from the inlet access port 3006.

In an example, the area 3118 in the wall 3120 located across from theinlet access port 3006 is beneath the inlet access port 3006. Thepuncture-resistant material may prevent or limit potential damage to thebody of the valve assembly by a needle or other device that may beinserted into the inlet access port. Further, in an example, the inletaccess port is positioned a threshold distance away from the inletone-way valve and/or the inlet lock (e.g. 2 mm or more. In someexamples, the threshold distance away from the inlet one-way valveand/or the inlet lock is 2 mm or more, 5 mm or more, or 7 mm or more,among other possibilities. Positioning the inlet access port thethreshold distance away from the inlet one-way valve and/or the inletlock may help may prevent or limit potential damage to the one-way valveand/or the inlet lock by a needle or other device that may be insertedinto the inlet access port.

In an example, the inlet access port may be configured to beinaccessible and/or hidden from view when the inlet lock is in thelocked position. For instance, with respect to FIG. 32A-B, valveassembly 3200 includes an inlet access port 3202 (see FIG. 32B) that is(i) inaccessible and hidden from view when adjustable inlet lock 3204 isin the locked position (see FIG. 32A) and (ii) accessible and visiblewhen adjustable inlet lock 3204 is in the unlocked position (see FIG.32B). In addition to providing aesthetic advantages, having an inletaccess port configured to be inaccessible and/or hidden from view whenthe inlet lock is in the locked position beneficially provides anadditional layer of protection, as the inlet access port is onlyaccessible when the adjustable inlet lock is in the unlocked position.

As mentioned above, valve assembly 2104, valve assembly 2504, and/orvalve assembly 104′ may include one or more of a pumping chamber accessport and an inlet access port. Thus, in some examples, valve assembly2104, valve assembly 2504, and/or valve assembly 104′ may include apumping chamber access port and not an inlet access port. In otherexamples, valve assembly 2104, valve assembly 2504, and/or valveassembly 104′ may include an inlet access port and not a pumping chamberaccess port. In this regard, as an illustrative example of a valveassembly with an inlet access port and not a pumping chamber accessport, FIG. 40 illustrates a valve assembly 4000 that includes an inletaccess port 4002 but not a pumping chamber access port.

In some examples, fluid-management system 2100, fluid-management system2500, fluid-management system 100′, and fluid-management system 100 mayeach further include a tube lock that is configured to lock the tube ata point that is external to the person's body and upstream of the valveassembly. As mentioned above, the fluid-management systems may include apumping chamber access port and/or an inlet access port that allowaccess for, e.g., flushing out one or more components of thefluid-management system. Such a tube lock may be configured to lock orclamp off the tube, which may be beneficial during flushing of thepumping chamber and/or the one-way valve(s). For instance, withreference to FIG. 30 , valve assembly 3000 may further include anadjustable tube lock 3022. Adjustable tube lock 3022 may be activated invarious ways so as to pinch tube 3024, thereby clamping the tube.

Various adjustable tube locks are possible. In this regard, theadjustable tube lock 3022 of FIG. 30 functions in a manner similar tothe twist pinch described with reference to FIGS. 7A-B and thus is notdescribed in as great of detail. However, adjustable tube lock 3022 maytake various other forms. For instance, adjustable tube lock 3022 maytake the form of a twist pinch, a pinch level, and an offset device(e.g., forms similar to the forms of the outlet locks illustrated inFIGS. 6A-B, 7A-B, 9A-C, and 10A-B), among other possibilities. Further,in some examples, adjustable tube lock 3022 is non-removably attached totube 3024.

Still further, in some examples, adjustable tube lock 3022 is removable.In this regard, as an illustrative example of an adjustable tube lockthat is removable, FIG. 41 illustrates an adjustable tube lock 4100 thattakes the form of a clamp that can be placed on the tube and removedfrom the tube as desired. For a valve assembly with an outlet lock andnot an inlet lock (e.g., valve assembly 4000 shown in FIG. 40 ),adjustable tube lock 4100 could be placed on the tube between thepumping chamber and the person's body. When the adjustable tube lock4100 is not placed on the tube, the access port may communicate with thebody cavity (e.g., pleural space). On the other hand, when theadjustable tube lock 4100 on the tube and clamps the tube at a pointbetween the pumping chamber and the person's body, the body cavity isisolated from the access port and pumping chamber. Further, the accessport may be in fluid communication with the inlet valve. If there is anocclusion in the pump chamber or one-way valves, pressure could beapplied (e.g., with a syringe) to clear the debris or blockage. Theaccess port may be a luer lock with a removable cup or a self-sealingneedless access port.

As mentioned above, adjustable tube lock 3022 may ensure that fluid isnot forced back into the body when pump chamber 3004 is flushed out viainlet access port 3006. Rather, adjustable tube lock 3022 will blockfluid from flowing upstream in tube 3024 beyond the adjustable tube lock3022, and instead fluid being used to flush out valve assembly 3000 willflow through the valves and out of the outlet of the fluid-managementsystem.

In some examples, the pumping chamber 2110 of fluid-management system2100, the pumping chamber 2510 of fluid-management system 2500, and/orthe pumping chamber 402 of fluid-management system 100′ are eachconfigured such that the distal end of the valve assembly is configuredto fit into a variety of different bottles, such as bottles that haveopenings of different sizes. In an example, the distal end of the valveassembly is tapered such that the distal end of the valve assembly mayfit into a plurality of bottle openings of different sizes. Further, inan example, the distal is tapered such that a tip of the valve assemblystays off the walls of the bottle. In this regard, the taper may besymmetrical about an axis of the valve assembly.

As an illustrative example, with reference to FIGS. 33A-B, valveassembly 3300 is configured such that distal end 3302 is able to fitinto bottle 3304. Distal end 3302 may be tapered such that a tip ofvalve assembly 3300 stays off the walls of bottle 3304 when it isinserted into the opening of the bottle. The taper be symmetrical aboutan axis 3306 of valve assembly.

In an example, bottle 3304 may have an externally-threaded openingconfigured to attached to a screw cap with an internal thread. Such anexternally-threaded opening configured to attached to a screw cap arecommon throughout various industries, including, for instance, themedical and food industry. As one example, soda bottles are commonlyprovided with such externally-threaded openings.

Furthermore, in an example, when the distal end of the valve assembly isinserted in the bottle, it may be beneficial to have a vent that allowsair to flow between the bottle and the valve assembly. In this regard,the pumping chamber may be configured to provide a vent when the valveassembly is positioned to drain into a bottle. The vent may take variousforms. As one possibility, the body of the pumping chamber may include adepression, so that when the pump chamber is positioned against thebottle opening, there is an air gap that allows are the flow between theinside of the bottle and the external environment. For instance, withreference to FIGS. 34A-B, pumping chamber 3400 includes a depression3402 in body 3404. FIG. 34B illustrates a cross sectional view of body3404 of pumping chamber 3400 taken along line C-C. When pumping chamber3400 is positioned against a bottle opening, depression 3402 provides anairgap that will allow flow between the inside of the bottle and pumpingchamber 3400 to the external environment. Other example vents arepossible as well.

In another example, in addition to or alternative to the distal endbeing configured to fit a bottle, the distal end may be configured toplug into other tubes. As mentioned above with respect to FIG. 17 ,valve assembly 104′ may be configured to connect to an indwellingcatheter 1702. Similarly, valve assembly 2104 and valve assembly 2504may also be configured to connect to another tube such as an externaltube. For instance, in an example, the distal end of fluid-managementsystem 2100, the distal end of fluid-management system 2500, the distalend of fluid management system 100, and/or distal end offluid-management system 100′ are each configured to attach to a tube. Inthis regard, as an illustrative example, FIG. 35 illustrates a valveassembly 3500 that includes (i) an adjustable outlet lock 3502 of thevalve assembly 3500 and (ii) an attachment system 3504 on a distal end3506 of the valve assembly 3500. The attachment system 3504 isconfigured to attach to a proximal end 3508 of tube 3510. Any suitableattachment system for connecting to proximal end 3508 of tube 3510 ispossible. In an example, attachment system 3504 may be configured toprovide an interference fit with proximal end 3508 of tube 3510.However, other attachment systems are possible as well. After connectingvalve assembly 3500 to tube 3510, a user may control adjustable outletlock 3502 (e.g., open and close adjustable outlet lock 112) to drainfluid from the body cavity and out a distal end (not shown) of tube 3510as desired. In an example, by being able to connect to an external tubesuch as tube 3510, a user (e.g., the patient or an individual assistingthe patient) may use the tube to drain into a reservoir that is notdirectly proximate to valve assembly 3500. In other words, the abilityto connect to an external tube may extend the reach of the fluidmanagement system, if desired. In an example, this ability to connect toan external tube could allow the fluid management system to perform as acontinuous drain thoracostomy tube should the need arise for continuousdrainage (e.g., such as when the patient may be admitted to a hospitaland/or intensive care unit (ICU)).

Other attachment systems for attaching to a tube are possible as well.As another illustrative example, FIGS. 42A-B illustrate a valve assembly4200 that includes an adjustable outlet lock 4202 of the valve assembly4200. FIG. 42A illustrates adjustable outlet lock 4202 in the closedposition, and FIG. 42B illustrates adjustable outlet lock 4202 in theopen position. Adjustable outlet lock 4202 has a taper 4204 that couldplug into a chest tube drain or suction tubing.

As yet another illustrative example, FIGS. 43A-B illustrate a valveassembly 4300 that includes an adjustable outlet lock 4302 of the valveassembly 4300. FIG. 43A illustrates adjustable outlet lock 4302 in theclosed position, and FIG. 43B illustrates adjustable outlet lock 4302 inthe open position. Adjustable outlet lock 4302 has a taper 4304 thatcould plug into a chest tube drain or suction tubing. Further, comparedto adjustable outlet lock 4202 of FIGS. 42A-B, adjustable outlet lock4302 has a flat area that could provide additional space for grippingthe adjustable outlet lock in order to rotate and unlock the outletlock.

Further, in some examples, the valve assembly may be configured toattach to a plurality of different adapters and/or caps. For instance,as an illustrative example, FIG. 44 illustrate a valve assembly 4400that is configured to attach to a plurality of different adapters 4402 aand 4402 b. Adapter 4402 a is an adapter that includes a wide base ontowhich is mounted a cylinder with progressively smaller externalthreading (and is commonly referred to as a “Christmas tree adapter”)and adapter 4402 b is a tapered adapter. In turn, the different adaptersmay serve a different function such as, for instance, connecting to adifferent type of tubing. In addition, valve assembly 4400 may also beconfigured to attach to one or more caps, such as cap 4402 c.

As mentioned above, in an example, one-way valve 110 may include aplurality of lips that define a slit that can move from a closedposition to an open position. For instance, with reference to FIGS.2A-B, one-way valve 110 may include first lip 202 and second lip 204that define slit 206. The lips 202 and 204 may be configured such that,when the lips are in the closed position, the surface area ofinteraction between the lips is relatively small. For instance, in anexample, the surface area of interaction is below 60 mm² and preferablyin a range 0.6 mm² to 6 mm².

Similarly, in some examples, the one-way valves 2112 and 2116 offluid-management system 2100 and the one-way valves 2512 and 2516 offluid-management system 2500 each include a plurality of lips thatdefine a slit that can move from a closed position to an open position.For instance, with reference to FIG. 36A, one-way valve 3600 may includefirst lip 3602 and second lip 3604 that define slit 3606. The lips 3602and 3604 may be configured such that, when the lips are in the closedposition, the surface area of interaction between the lips is relativelysmall. The surface area of interaction may be the length×width of thelips, as shown in FIG. 36A. Various surface areas of interaction arepossible. For instance, in an example, the surface area of interactionmay be less than 60 mm², and as specific examples, less than 55 mm²,less than 50 mm², less than 45 mm², less than 40 mm², less than 35 mm²,less than 30 mm², less than 25 mm², less than 20 mm², less than 15 mm²,less than 10 mm², less than 9 mm², less than 8 mm², less than 7 mm²,less than 6 mm², less than 5 mm², less than 4 mm², less than 3 mm², lessthan 2 mm², or less than 1 mm², among other possibilities. Such asurface area of interaction may help ensure that the one-way valve workswell both when wet and dry.

Further, in some examples, the surface area of interaction may begreater than 0.6 mm². In some examples, the surface area of interactionmay be in a range between 0.6 mm² to 60 mm², in a range between 0.6 mm²to 55 mm², in a range between 0.6 mm² to 50 mm², in a range between 0.6mm² to 45 mm², in a range between 0.6 mm² to 40 mm², in a range between0.6 mm² to 35 mm², in a range between 0.6 mm² to 30 mm², in a rangebetween 0.6 mm² to 25 mm², in a range between 0.6 mm² to 20 mm², in arange between 0.6 mm² to 15 mm², in a range between 0.6 mm² to 10 mm²,in a range between 0.6 mm² to 9 mm², in a range between 0.6 mm² to 8mm², in a range between 0.6 mm² to 7 mm², in a range between 0.6 mm² to6 mm², in a range between 0.6 mm² to 5 mm², in a range between 0.6 mm²to 4 mm², in a range between 0.6 mm² to 3 mm², in a range between 0.6mm² to 2 mm², or in a range between 0.6 mm² to 1 mm², among otherpossibilities. Such a surface area of interaction may help ensure thatthe one-way valve works well both when wet and dry.

FIGS. 36B-D illustrate one-way valve 3600 in different conditions. Inparticular, FIG. 36B illustrates one-way valve 3600 in a dry orsubstantially dry condition, FIG. 36C illustrates one-way valve 3600 ina wet or partially wet condition, and FIG. 36D illustrates one-way valve3600 in a fully wetted condition. Such a surface area of interaction mayhelp ensure that the one-way valve works well in these variousconditions illustrated in FIGS. 36B-D.

In some examples, in order to prevent blocking or clogging of thedisclosed fluid-management systems 2100 and 2500, one or more componentsof the fluid-management systems may be coated in anticoagulation factorsor fibrinolytic factors. For example, the components or surfaces (e.g.,internal and/or external surfaces) of valve assemblies 2104, 2504 and/orimplanted tube 2122, 2522 may be coated at least in part withanticoagulation factors or fibrinolytic factors. For instance, withreference to FIGS. 21A-D, internal portions and/or external portions ofthe body of pumping chamber 2110, one-way valves 2112, 2116, and/orinternal portions of tube 2122 may be coated in anticoagulation factorsor fibrinolytic factors. Further, with reference to FIGS. 25A-D,internal and/or external portions of pumping chamber 2510, one-wayvalves 2512, 2516, and/or internal portions of tube 2522 may be coatedin anticoagulation factors or fibrinolytic factors. Other components maybe coated with anticoagulation factors or fibrinolytic factors as well.

As mentioned above, the presence of the anticoagulation factors mayreduce the amount of clotting that would otherwise occur if they werenot present. Further, examples of anticoagulation factors includeheparin, low molecular weight heparin, fondaparinux, idraparinux,idrabiotaparinux, diabigatran, rivaroxaban, apixan, betrixaban,edoxaban, darexaban, letaxaban, eribaxaban, hirudin, lepirudin,bivalirudin, argatroban, dabigatran, ximelagatran, hementin, vitamin E,coumarin, warfarin, acenocoumarol, phenprocoumon, atromentin,phenindione, brodifacoum, and difenacoum. Examples of fibrinolyticfactors include plasmin, tissue plasminogen activator, urokinase,streptokinase, plasminogen activator inhibitor-1 inhibitor, andplasminogen activator inhibitor-2 inhibitor. Other examples ofanticoagulation factors or fibrinolytics may be used.

Example methods for facilitating draining of fluid from a body cavityand for draining fluid from a body cavity are also provided. Suchmethods could, for example, be carried out by fluid-management systems2100, and/or 2500 as described with reference to FIGS. 21A-36 and/orutilizing fluid-management systems 2100 or 2500.

FIG. 37 shows a flowchart of an example method 3700 of fluid management.It should be understood that for this and other processes and methodsdisclosed herein, flowcharts show functionality and operation of onepossible implementation of present embodiments. Alternativeimplementations are included within the scope of the example embodimentsof the present disclosure in which functions may be executed out oforder from that shown or discussed, including substantially concurrentor in reverse order, depending on the functionality involved, as wouldbe understood by those reasonably skilled in the art.

At block 3702, method 3700 involves providing a fluid-management systemfor selectively draining fluid from a body cavity. The fluid-managementsystem comprises a valve assembly and a tube for carrying fluid from abody cavity of a person to the valve assembly, wherein the valveassembly is positioned external to the person's body and comprises (i)an inlet, (ii) an outlet, (iii) a pumping chamber between the inlet andoutlet and configured to be compressed and decompressed to pump fluid,(iv) a first one-way valve positioned on a first side of the pumpingchamber, (v) a second one-way valve positioned on a second side of thepumping chamber, and (vi) an adjustable inlet lock configured toselectively prevent fluid movement through the inlet, and wherein thetube is configured to extend from the inlet of the valve assembly to theperson's body cavity. In some examples, the fluid-management systemfurther includes an adjustable outlet lock configured to selectivelyprevent fluid movement through the outlet, wherein the adjustable outletlock is positioned downstream of the second one-way valve.

At block 3704, method 3700 involves implanting a portion of thefluid-management system into the person's body, such that a proximal endof the tube is in fluid communication with the cavity and the valveassembly is positioned external to the person's body. At block 3706,after the fluid-management system is implanted into the person's body,the person may selectively drain fluid from the body cavity using thefluid-management system, as described above.

FIG. 38 shows a flowchart of an example method 3800 of draining fluidfrom a body cavity of a person to a reservoir external to the person'sbody. In particular, method 3800 is a method of operation of afluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly,wherein the valve assembly is positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) a pumping chamberbetween the inlet and outlet and configured to be compressed anddecompressed to pump fluid, (iv) a first one-way valve positioned on afirst side of the pumping chamber, (v) a second one-way valve positionedon a second side of the pumping chamber, and (vi) an adjustable inletlock configured to selectively prevent fluid movement through the inlet,and wherein the tube is configured to extend from the inlet of the valveassembly to the person's body cavity. In some examples, thefluid-management system further includes an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet,wherein the adjustable outlet lock is positioned downstream of thesecond one-way valve.

At block 3802, method 3800 involves while the adjustable inlet lock isin a locked position, the adjustable inlet lock preventing fluidmovement through the inlet and the outlet. At block 3804, method 3800involves while the adjustable inlet lock is in an unlocked position,each of the one-way valves opening and closing based on compression anddecompression of the pumping chamber, so as to provide a pumping actionto move fluid from the body cavity through the tube, into the inlet, andout of the outlet to an exterior reservoir.

FIG. 39 shows a flowchart of an example method 3900 of draining fluidfrom a body cavity of a person to a reservoir external to the person'sbody. In particular, method 3900 is a method of operation of afluid-management system comprising a valve assembly and a tube forcarrying fluid from a body cavity of a person to the valve assembly,wherein the valve assembly is positioned external to the person's bodyand comprises (i) an inlet, (ii) an outlet, (iii) a pumping chamberbetween the inlet and outlet and configured to be compressed anddecompressed to pump fluid, (iv) a first one-way valve positioned on afirst side of the pumping chamber, (v) a second one-way valve positionedon a second side of the pumping chamber, and (vi) an adjustable inletlock configured to selectively prevent fluid movement through the inlet,and wherein the tube is configured to extend from the inlet of the valveassembly to the person's body cavity. In some examples, thefluid-management system further includes an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet,wherein the adjustable outlet lock is positioned downstream of thesecond one-way valve.

At block 3902, method 3900 involves, while the adjustable inlet lock isin a locked position, an external portion of the fluid-management systemattaching to a body of the person. The external portion of thefluid-management system may attach to a body of the person in variousways, such as the various ways discussed above with reference to FIGS.13-15B. In an example, the fluid-management system attaches to a chestwall of the person. At block 3904, method 3900 involves, while theadjustable inlet lock is in an unlocked position, the pumping chambercompressing and decompressing, so as to provide a pumping action toprime the fluid-management system and get fluid moving through thefluid-management system. Further, at block 3906, method 3900 involves,while the adjustable inlet lock is in the unlocked position, after thefluid-management system is primed, the fluid-management system siphoningfluid from the body cavity through the fluid-management system. Thefluid may be drained to a reservoir external to the person's body.

In an example, the fluid-management system siphons fluid from the bodycavity through the fluid-management system after the fluid-managementsystem is primed and while the pump chamber is positioned below a levelof fluid in the body cavity. For instance, in an example, pump chambers2110, 2510 are shown positioned below a level of fluid in the bodycavity in FIGS. 21D and 25D, respectively. In some examples, the tubemay be longer and pump chambers 2110, 2510 may be positioned furtherbelow the level of fluid in the body cavity than shown in in FIGS. 21Dand 25D. In other examples, pump chambers 2110, 2510 may be positionedabove the level of fluid in the body cavity.

In some examples, the position at which the pump chamber is placedrelative to the level of fluid in the body to facilitate siphoning mayvary depending on the body cavity being drained. For example, theposition at which the pump chamber is placed relative to the level offluid in the body to facilitate siphoning may be different for a firstbody cavity (e.g., a pleural cavity) than for a second body cavity(e.g., a cystic lesion in the abdomen). In this regard, for the pleuralspace, the chest wall tends to recoil outward and the lung tends torecoil inward. When the pleural fluid drains and the pleural spacestarts to become empty of fluid, this tends to create a negativepressure.

In some patients with significant pleural scarring, lung recoil can beexaggerated and lung recoil (and hence negative pressure) can be evenworse. In such a case, the pump chamber outlet may need to be below thelevel of the fluid by at least the amount of vacuum as measured in cmH₂O (making the assumption that pleural fluid density is equal to orsubstantially equal to water density). On the other hand, for theabdomen, the pressures tend to be positive, so the pump chamber outletmay not need to get below the level of fluid to facilitate siphoning.

Thus, in some examples, the tip may be positioned at any level where thehydrostatic pressure column above the pump chamber outlet is sufficientto overcome any potential negative pressure (vacuum) in the body cavity.Therefore, in some examples, method 3900 involves the fluid-managementsystem siphoning fluid from the body cavity through the fluid-managementsystem after the fluid-management system is primed and while at least aportion of the pump chamber (e.g., the tip or distal end of the pumpchamber) is positioned at a level where the hydrostatic pressure columnabove the pump chamber outlet is sufficient to overcome any potentialnegative pressure (vacuum) in the body cavity.

Example embodiments of the disclosed innovations have been describedabove. Those skilled in the art will understand, however, that changesand modifications may be made to the embodiments described withoutdeparting from the true scope and spirit of the present invention, whichwill be defined by the claims. Further, to the extent that examplesdescribed herein involve operations performed or initiated by actors,such as “persons” or other entities, this is for purposes of example andexplanation only. The claims should not be construed as requiring actionby such actors unless explicitly recited in the claim language.

1-20. (canceled)
 21. A valve assembly comprising: an inlet; an outlet; aplurality of one-way valves positioned between the inlet and outlet; andan adjustable outlet lock positioned downstream of the plurality ofone-way valves and configured to selectively prevent fluid movementthrough the outlet, wherein the valve assembly is configured to (i) bepositioned external to a body of a person and (ii) attach to a tube forcarrying fluid from a body cavity of the person to the valve assembly.22. The valve assembly of claim 21, wherein the inlet is configured toattach to the tube, and wherein the tube is configured to extend fromthe inlet to the person's body cavity.
 23. The valve assembly of claim21, wherein the valve assembly comprises a pumping chamber that housesthe plurality of one-way valves, wherein the plurality of one-way valvescomprise a first one-way valve positioned on a first side of the pumpingchamber and a second one-way valve positioned on a second side of thepumping chamber, and wherein the pumping chamber is configured to becompressed and decompressed to pump fluid.
 24. The valve assembly ofclaim 23, wherein each one-way valve of the plurality of one-way valvesis configured to open and close based on compression and decompressionof the pumping chamber.
 25. The valve assembly of claim 24, wherein eachone-way valve of the plurality of one-way valves is further configuredto open and close based on fluctuations in pressure between the person'sbody cavity and the one-way valve that occur based on respiratory actionof a breathing cycle of the person.
 26. The valve assembly of claim 25,wherein each one-way valve of the plurality of one-way valves isconfigured to (i) open due to positive pressure between the person'sbody cavity and the one-way valve during an expiration phase of thebreathing cycle and (ii) close due to negative pressure between theperson's body cavity and the one-way valve during an inspiration phaseof the breathing cycle.
 27. The valve assembly of claim 21, wherein theadjustable outlet lock of the valve assembly is non-removably attachedto the valve assembly.
 28. The valve assembly of claim 21, wherein theadjustable outlet lock is positioned at the outlet.
 29. The valveassembly of claim 21, wherein each one-way valve of the plurality ofone-way valves is configured to open with a cracking pressure of lessthan about 25 cmH₂O.
 30. The valve assembly of claim 21, wherein thecracking pressure is less than about 5 cmH₂O.
 31. The valve assembly ofclaim 21, wherein each one-way valve of the plurality of one-way valvesis configured to prevent retrograde flow.
 32. The valve assembly ofclaim 31, wherein each one-way valve of the plurality of one-way valvesis configured to reseal with a differential back pressure of less thanabout 15 cmH₂O.
 33. The valve assembly of claim 32, wherein thedifferential back pressure is less than about 2 cmH₂O.
 34. The valveassembly of claim 21, wherein each one-way valve of the plurality ofone-way valves comprises a plurality of lips defining a slit that ismovable from a closed position to an open position, and wherein the lipsare configured to have a surface area of interaction of less than 6millimeters² when the slit is in the closed position.
 35. The valveassembly of claim 21, wherein the adjustable outlet lock is located atthe outlet, and wherein the adjustable outlet lock is configured to movebetween a locked position in which the adjustable outlet lock seals theoutlet and an unlocked position in which the adjustable outlet lockallows fluid movement through the outlet.
 36. The valve assembly ofclaim 35, wherein the adjustable outlet lock comprises at least one of acap, a pinch lever, a twist pinch, or an offset device.
 37. The valveassembly of claim 21, wherein the valve assembly comprises a body thathouses the plurality of one-way valves, and wherein the body is coatedwith at least one of anticoagulation factors or fibrinolytic factors.38. The valve assembly of claim 21, wherein the cavity comprises one ofa pleural cavity, a peritoneal cavity, a cerebrospinal cavity, apericardial cavity, a breast cavity, or a cavity of a cystic lesion. 39.A valve assembly comprising: an inlet; an outlet; one or more one-wayvalves positioned between the inlet and outlet, wherein each of the oneor more one-way valves is configured to allow fluid movement in onedirection during a fluid draining process and prevent retrograde flowduring the fluid draining process; and an adjustable outlet lockpositioned downstream of the one or more one-way valves and configuredto selectively prevent fluid movement through the outlet, wherein thevalve assembly is configured to (i) be positioned external to a body ofa person and (ii) attach to a tube for carrying fluid from a body cavityof the person to the valve assembly.
 40. The valve assembly of claim 39,wherein the valve assembly is non-removably attached to the tube forcarrying fluid from the body cavity of the person to the valve assembly.41. The valve assembly of claim 39, wherein the adjustable outlet lockof the valve assembly is non-removably attached to the valve assembly.42. The valve assembly of claim 39, wherein the adjustable outlet lockof the valve assembly is removable.
 43. The valve assembly of claim 39,wherein the inlet is configured to attach to the tube, and wherein thetube is configured to extend from the inlet to the person's body cavity.44. A valve assembly comprising: an inlet; an outlet; one or moreone-way valves positioned between the inlet and outlet, wherein each ofthe one or more one-way valves is configured to allow fluid movement inone direction during a fluid draining process and prevent retrogradeflow during the fluid draining process; and an adjustable outlet lockconfigured to selectively prevent fluid movement through the outlet,wherein the valve assembly is configured to be positioned external to abody of a person, wherein the valve assembly is non-removably attachedto a tube for carrying fluid from a body cavity of the person to thevalve assembly, and wherein the adjustable outlet lock of the valveassembly is non-removably attached to the valve assembly.
 45. The valveassembly of claim 44, wherein the adjustable outlet lock is positioneddownstream of the one or more one-way valves.